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119-579: Biomedical engineering and Biotechnology alike are often loosely called Biomedical Technology or Bioengineering . The Biomedical technology field is currently growing at a rapid pace. Biomedical news has often been reported on various platforms, including the MediUnite Journal; and required jobs for the industry expect to grow 23% by 2024, and with the pay averaging over $ 86,000. Biomedical technology involves: Biomedical technologies: This article about biological engineering

238-562: A Ph.D. is notably more common than in others, it is hardly ever the majority (except in academia). In fact, the perceived need for some kind of graduate credential is so strong that some undergraduate BME programs will actively discourage students from majoring in BME without an expressed intention to also obtain a master's degree or apply to medical school afterwards. Graduate programs in BME, like in other scientific fields, are highly varied, and particular programs may emphasize certain aspects within

357-488: A Rehab' Engineer in the UK is possible via a University BSc Honours Degree course such as Health Design & Technology Institute, Coventry University. The rehabilitation process for people with disabilities often entails the design of assistive devices such as Walking aids intended to promote the inclusion of their users into the mainstream of society, commerce, and recreation. Regulatory issues have been constantly increased in

476-469: A biological specimen is required, and images can be obtained "non-contact" or through a transparent window or membrane. The laser output from the instruments used is low – eye-safe near-infrared or visible-light  – and no damage to the sample is therefore likely. The principle of OCT is white light, or low coherence, interferometry. The optical setup typically consists of an interferometer (Fig. 1, typically Michelson type) with

595-482: A broadly tunable laser with narrow linewidth . The first demonstration of OCT imaging (in vitro) was published by a team from MIT and Harvard Medical School in a 1991 article in the journal Science . The article introduced the term "OCT" to credit its derivation from optical coherence-domain reflectometry , in which the axial resolution is based on temporal coherence . The first demonstrations of in vivo OCT imaging quickly followed. The first US patents on OCT by

714-1046: A complementary technique to X-ray to monitor lower extremity trauma. The sensor monitor the dielectric properties and can thus notice change in tissue (bone, muscle, fat etc.) under the skin so when measuring at different times during the healing process the response from the sensor will change as the trauma heals. Clinical engineering is the branch of biomedical engineering dealing with the actual implementation of medical equipment and technologies in hospitals or other clinical settings. Major roles of clinical engineers include training and supervising biomedical equipment technicians (BMETs) , selecting technological products/services and logistically managing their implementation, working with governmental regulators on inspections/audits, and serving as technological consultants for other hospital staff (e.g. physicians, administrators, I.T., etc.). Clinical engineers also advise and collaborate with medical device producers regarding prospective design improvements based on clinical experiences, as well as monitor

833-579: A cross-disciplinary hybrid specialization of other disciplines; and BME programs at all levels are becoming more widespread, including the Bachelor of Science in Biomedical Engineering which includes enough biological science content that many students use it as a " pre-med " major in preparation for medical school . The number of biomedical engineers is expected to rise as both a cause and effect of improvements in medical technology. In

952-808: A discussion of the procedures used to design safe systems. The clinical engineering department is constructed with a manager, supervisor, engineer, and technician. One engineer per eighty beds in the hospital is the ratio. Clinical engineers are also authorized to audit pharmaceutical and associated stores to monitor FDA recalls of invasive items. Rehabilitation engineering is the systematic application of engineering sciences to design, develop, adapt, test, evaluate, apply, and distribute technological solutions to problems confronted by individuals with disabilities. Functional areas addressed through rehabilitation engineering may include mobility, communications, hearing, vision, and cognition, and activities associated with employment, independent living, education, and integration into

1071-440: A dispersive element (see Fig. 4). Thereby the information of the full depth scan can be acquired within a single exposure. However, the large signal-to-noise advantage of FD-OCT is reduced due to the lower dynamic range of stripe detectors with respect to single photosensitive diodes, resulting in an SNR advantage of ~10 dB at much higher speeds. This is not much of a problem when working at 1300 nm, however, since dynamic range

1190-438: A distance of meters. In OCT, this interference is shortened to a distance of micrometers, owing to the use of broad-bandwidth light sources (i.e., sources that emit light over a broad range of frequencies). Light with broad bandwidths can be generated by using superluminescent diodes or lasers with extremely short pulses ( femtosecond lasers ). White light is an example of a broadband source with lower power. Light in an OCT system

1309-453: A doctoral (Ph.D., or MD-PhD ) degree in BME (Biomedical Engineering) or another branch of engineering with considerable potential for BME overlap. As interest in BME increases, many engineering colleges now have a Biomedical Engineering Department or Program, with offerings ranging from the undergraduate (B.Sc., B.S., B.Eng. or B.S.E.) to doctoral levels. Biomedical engineering has only recently been emerging as its own discipline rather than

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1428-484: A focus area in research, such as with hepatic assist devices that use liver cells within an artificial bioreactor construct. Genetic engineering, recombinant DNA technology, genetic modification/manipulation (GM) and gene splicing are terms that apply to the direct manipulation of an organism's genes. Unlike traditional breeding, an indirect method of genetic manipulation, genetic engineering utilizes modern tools such as molecular cloning and transformation to directly alter

1547-419: A frequency expressed as where ν 0 {\displaystyle \nu _{0}} is the central optical frequency of the source, v s {\displaystyle v_{s}} is the scanning velocity of the pathlength variation, and c {\displaystyle c} is the speed of light. The axial and lateral resolutions of OCT are decoupled from one another;

1666-448: A less formal way, bioinformatics also tries to understand the organizational principles within nucleic acid and protein sequences. Biomechanics is the study of the structure and function of the mechanical aspects of biological systems, at any level from whole organisms to organs , cells and cell organelles , using the methods of mechanics . A biomaterial is any matter, surface, or construct that interacts with living systems. As

1785-468: A low coherence, broad bandwidth light source. Light is split into and recombined from reference and sample arms, respectively. In time domain OCT the path length of the reference arm is varied in time (the reference mirror is translated longitudinally). A property of low coherence interferometry is that interference, i.e. the series of dark and bright fringes, is only achieved when the path difference lies within

1904-474: A part of pharmacy due to its focus on the use of technology on chemical agents in providing better medicinal treatment. This is an extremely broad category —essentially covering all health care products that do not achieve their intended results through predominantly chemical (e.g., pharmaceuticals) or biological (e.g., vaccines) means, and do not involve metabolism. A medical device is intended for use in: Some examples include pacemakers , infusion pumps ,

2023-505: A prominent biomedical imaging technique that has continually improved in technical performance and range of applications. The improvement in image acquisition rate is particularly spectacular, starting with the original 0.8 Hz axial scan repetition rate to the current commercial clinical OCT systems operating at several hundred kHz and laboratory prototypes at multiple MHz. The range of applications has expanded from ophthalmology to cardiology and other medical specialties. For their roles in

2142-438: A science, biomaterials is about fifty years old. The study of biomaterials is called biomaterials science or biomaterials engineering . It has experienced steady and strong growth over its history, with many companies investing large amounts of money into the development of new products. Biomaterials science encompasses elements of medicine, biology, chemistry, tissue engineering and materials science. Biomedical optics combines

2261-463: A similar way, combination with near-infrared spectroscopy (NIRS) has been implemented. Endoscopic/intravascular OCT has been further developed for use in neurovascular applications including imaging for guiding endovascular treatment of ischemic stroke and brain aneurysms. Initial clinical investigations with existing coronary OCT catheters have been limited to proximal intracranial anatomy of patient with limited tortuosity, as coronary OCT technology

2380-562: A spectrometer. An implementation of SS-OCT was described by the MIT group as early as 1994.   A group based in the University of Vienna described measurement of intraocular distance using both tunable laser and spectrometer-based interferometry as early as 1995. SD-OCT imaging was first demonstrated both in vitro and in vivo by a collaboration between the Vienna group and a group based in

2499-871: A variety of applications. The potential to use interferometry for imaging was proposed, and measurement of retinal elevation profile and thickness had been demonstrated. The initial commercial clinical OCT systems were based on point-scanning TD-OCT technology, which primarily produced cross-sectional images due to the speed limitation (tens to thousands of axial scans per second). Fourier-domain OCT became available clinically 2006, enabling much greater image acquisition rate (tens of thousands to hundreds of thousands axial scans per second) without sacrificing signal strength. The higher speed allowed for three-dimensional imaging, which can be visualized in both en face and cross-sectional views. Novel contrasts such as angiography , elastography , and optoretinography also became possible by detecting signal change over time. Over

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2618-458: Is a stub . You can help Misplaced Pages by expanding it . Biomedical engineering Biomedical engineering ( BME ) or medical engineering is the application of engineering principles and design concepts to medicine and biology for healthcare applications (e.g., diagnostic or therapeutic purposes). BME is also traditionally logical sciences to advance health care treatment, including diagnosis , monitoring , and therapy . Also included under

2737-501: Is a kind of medical device made to replace and act as a missing biological structure (as compared with a transplant, which indicates transplanted biomedical tissue). The surface of implants that contact the body might be made of a biomedical material such as titanium, silicone or apatite depending on what is the most functional. In some cases, implants contain electronics, e.g. artificial pacemakers and cochlear implants. Some implants are bioactive, such as subcutaneous drug delivery devices in

2856-599: Is a major segment of biotechnology – which overlaps significantly with BME. One of the goals of tissue engineering is to create artificial organs (via biological material) for patients that need organ transplants. Biomedical engineers are currently researching methods of creating such organs. Researchers have grown solid jawbones and tracheas from human stem cells towards this end. Several artificial urinary bladders have been grown in laboratories and transplanted successfully into human patients. Bioartificial organs, which use both synthetic and biological component, are also

2975-697: Is adaptable to perform both inline and off-line. Due to the high volume of produced pills, an interesting field of application is in the pharmaceutical industry to control the coating of tablets. Fiber-based OCT systems are particularly adaptable to industrial environments. These can access and scan interiors of hard-to-reach spaces, and are able to operate in hostile environments—whether radioactive, cryogenic, or very hot. Novel optical biomedical diagnostic and imaging technologies are currently being developed to solve problems in biology and medicine. As of 2014, attempts have been made to use optical coherence tomography to identify root canals in teeth, specifically canal in

3094-420: Is an imaging technique that uses interferometry with short- coherence-length light to obtain micrometer-level depth resolution and uses transverse scanning of the light beam to form two- and three-dimensional images from light reflected from within biological tissue or other scattering media. Short-coherence-length light can be obtained using a superluminescent diode (SLD) with a broad spectral bandwidth or

3213-408: Is based on light, rather than sound or radio frequency. An optical beam is directed at the tissue, and the small portion of this light that reflects directly back from sub-surface features is collected. Note that most light scatters off at large angles. In conventional imaging, this diffusely scattered light contributes background that obscures an image. However, in OCT, a technique called interferometry

3332-560: Is believed to be safe and effective when used as intended, and, therefore, it can be marketed within the European Union area. The different regulatory arrangements sometimes result in particular technologies being developed first for either the U.S. or in Europe depending on the more favorable form of regulation. While nations often strive for substantive harmony to facilitate cross-national distribution, philosophical differences about

3451-399: Is broken into two arms – a sample arm (containing the item of interest) and a reference arm (usually a mirror). The combination of reflected light from the sample arm and reference light from the reference arm gives rise to an interference pattern, but only if light from both arms have traveled the "same" optical distance ("same" meaning a difference of less than a coherence length). By scanning

3570-582: Is common as a new field transitions from being an interdisciplinary specialization among already-established fields to being considered a field in itself. Much of the work in biomedical engineering consists of research and development , spanning a broad array of subfields (see below). Prominent biomedical engineering applications include the development of biocompatible prostheses , various diagnostic and therapeutic medical devices ranging from clinical equipment to micro-implants, imaging technologies such as MRI and EKG / ECG , regenerative tissue growth, and

3689-428: Is effectively "optical ultrasound", imaging reflections from within tissue to provide cross-sectional images. OCT has attracted interest among the medical community because it provides tissue morphology imagery at much higher resolution (less than 10 μm axially and less than 20 μm laterally ) than other imaging modalities such as MRI or ultrasound. The key benefits of OCT are: OCT delivers high resolution because it

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3808-458: Is either filtered or generated in single successive frequency steps and reconstructed before Fourier transformation. By accommodation of a frequency scanning light source (i.e. frequency scanning laser) the optical setup (see Fig. 3) becomes simpler than spectral domain OCT, but the problem of scanning is essentially translated from the TD-OCT reference arm into the swept source OCT light source. Here

3927-533: Is not a serious problem at this wavelength range. The drawbacks of this technology are found in a strong fall-off of the SNR, which is proportional to the distance from the zero delay and a sinc -type reduction of the depth-dependent sensitivity because of limited detection linewidth. (One pixel detects a quasi-rectangular portion of an optical frequency range instead of a single frequency, the Fourier transform leads to

4046-438: Is similar to ultrasound imaging . Other medical imaging techniques such as computerized axial tomography, magnetic resonance imaging, or positron emission tomography do not use the echo-location principle. The technique is limited to imaging 1 to 2 mm below the surface in biological tissue, because at greater depths the proportion of light that escapes without scattering is too small to be detected. No special preparation of

4165-702: Is the principal healthcare regulatory authority in the United States, having jurisdiction over medical devices, drugs, biologics, and combination products. The paramount objectives driving policy decisions by the FDA are safety and effectiveness of healthcare products that have to be assured through a quality system in place as specified under 21 CFR 829 regulation . In addition, because biomedical engineers often develop devices and technologies for "consumer" use, such as physical therapy devices (which are also "medical" devices), these may also be governed in some respects by

4284-518: Is used in the intravascular evaluation of coronary artery plaques and to guide stent placement. Beyond ophthalmology and cardiology, applications are also developing in other medical specialties such as dermatology , gastroenterology (endoscopy), neurology , oncology , and dentistry . Interferometric reflectometry of biological tissue, especially of the human eye using short-coherence-length light (also referred to as partially-coherent, low-coherence, or broadband, broad-spectrum, or white light)

4403-518: Is used to analyze different layers in a painting. OCT has interesting advantages over other medical imaging systems. Medical ultrasonography , magnetic resonance imaging (MRI), confocal microscopy, and OCT are differently suited to morphological tissue imaging: while the first two have whole body but low resolution imaging capability (typically a fraction of a millimeter), the third one can provide images with resolutions well below 1 micrometer (i.e. sub-cellular), between 0 and 100 micrometers in depth, and

4522-513: Is used to image coronary arteries to visualize vessel wall lumen morphology and microstructure at a resolution ~10 times higher than other existing modalities such as intravascular ultrasounds , and x-ray angiography ( intracoronary optical coherence tomography ). For this type of application, 1 mm in diameter or smaller fiber-optics catheters are used to access artery lumen through semi-invasive interventions such as percutaneous coronary interventions . The first demonstration of endoscopic OCT

4641-455: Is used to record the optical path length of received photons, allowing rejection of most photons that scatter multiple times before detection. Thus OCT can build up clear 3D images of thick samples by rejecting background signal while collecting light directly reflected from surfaces of interest. Within the range of noninvasive three-dimensional imaging techniques that have been introduced to the medical research community, OCT as an echo technique

4760-674: Is widely used in basic science research applications. Ocular (or ophthalmic) OCT is used heavily by ophthalmologists and optometrists to obtain high-resolution images of the retina and anterior segment . Owing to OCT's capability to show cross-sections of tissue layers with micrometer resolution, OCT provides a straightforward method of assessing cellular organization , photoreceptor integrity , and axonal thickness in glaucoma , macular degeneration , diabetic macular edema , multiple sclerosis , optic neuritis, and other eye diseases or systemic pathologies which have ocular signs. Additionally, ophthalmologists leverage OCT to assess

4879-530: The retina in the eye or the coronary arteries in the heart. Fluorescence microscopy involves labeling specific molecules with fluorescent dyes and visualizing them using light, providing insights into biological processes and disease mechanisms. More recently, adaptive optics is helping imaging by correcting aberrations in biological tissue, enabling higher resolution imaging and improved accuracy in procedures such as laser surgery and retinal imaging. Tissue engineering, like genetic engineering (see below),

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4998-562: The Consumer Product Safety Commission . The greatest hurdles tend to be 510K "clearance" (typically for Class 2 devices) or pre-market "approval" (typically for drugs and class 3 devices). In the European context, safety effectiveness and quality is ensured through the "Conformity Assessment" which is defined as "the method by which a manufacturer demonstrates that its device complies with the requirements of

5117-436: The heart-lung machine , dialysis machines, artificial organs , implants , artificial limbs , corrective lenses , cochlear implants , ocular prosthetics , facial prosthetics , somato prosthetics, and dental implants . Stereolithography is a practical example of medical modeling being used to create physical objects. Beyond modeling organs and the human body, emerging engineering techniques are also currently used in

5236-590: The optimal extent of regulation can be a hindrance; more restrictive regulations seem appealing on an intuitive level, but critics decry the tradeoff cost in terms of slowing access to life-saving developments. Directive 2011/65/EU, better known as RoHS 2 is a recast of legislation originally introduced in 2002. The original EU legislation "Restrictions of Certain Hazardous Substances in Electrical and Electronics Devices" (RoHS Directive 2002/95/EC)

5355-514: The EU will take the more severe approach of requiring all applicable devices being placed on the market to consider the home healthcare standard. AS/ANS 3551:2012 is the Australian and New Zealand standards for the management of medical devices. The standard specifies the procedures required to maintain a wide range of medical assets in a clinical setting (e.g. Hospital). The standards are based on

5474-642: The European Medical Device Directive ". The directive specifies different procedures according to the class of the device ranging from the simple Declaration of Conformity (Annex VII) for Class I devices to EC verification (Annex IV), Production quality assurance (Annex V), Product quality assurance (Annex VI) and Full quality assurance (Annex II). The Medical Device Directive specifies detailed procedures for Certification. In general terms, these procedures include tests and verifications that are to be contained in specific deliveries such as

5593-561: The European Member States. The Notified Bodies must ensure the effectiveness of the certification process for all medical devices apart from the class I devices where a declaration of conformity produced by the manufacturer is sufficient for marketing. Once a product has passed all the steps required by the Medical Device Directive, the device is entitled to bear a CE marking , indicating that the device

5712-481: The IEC 606101 standards. The standard covers a wide range of medical equipment management elements including, procurement, acceptance testing, maintenance (electrical safety and preventive maintenance testing) and decommissioning. Biomedical engineers require considerable knowledge of both engineering and biology, and typically have a Bachelor's (B.Sc., B.S., B.Eng. or B.S.E.) or Master's (M.S., M.Sc., M.S.E., or M.Eng.) or

5831-577: The MIT/Harvard group described a time-domain OCT (TD-OCT) system. These patents were licensed by Zeiss and formed the basis of the first generations of OCT products until 2006. Tanno et al. obtained a patent on optical heterodyne tomography (similar to TD-OCT) in Japan in the same year. In the decade preceding the invention of OCT, interferometry with short-coherence-length light had been investigated for

5950-528: The Michelson interferometer where a microscope objective is used in both arms. Furthermore, while the temporal coherence of the source must remain low as in classical OCT (i.e. a broad spectrum), the spatial coherence must also be low to avoid parasitical interferences (i.e. a source with a large size). Optical coherence tomography is an established medical imaging technique and is used across several medical specialties including ophthalmology and cardiology and

6069-556: The Nicholas Copernicus University in a series of articles between 2000 and 2002. The SNR advantage of FD-OCT over TD-OCT was first demonstrated in eye imaging and further analyzed by multiple groups of researchers in 2003. Spectral-domain OCT (spatially encoded frequency domain OCT) extracts spectral information by distributing different optical frequencies onto a detector stripe (line-array CCD or CMOS) via

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6188-522: The U.S., an increasing number of undergraduate programs are also becoming recognized by ABET as accredited bioengineering/biomedical engineering programs. As of 2023, 155 programs are currently accredited by ABET. In Canada and Australia, accredited graduate programs in biomedical engineering are common. For example, McMaster University offers an M.A.Sc, an MD/PhD, and a PhD in Biomedical engineering. The first Canadian undergraduate BME program

6307-446: The addition of a wide range of technologies enabled key milestones in this computational imaging technique. High-speed axial and lateral scanners, ultra-broad spectrum or ultra-fast spectrally tunable lasers or other high brightness radiation sources, increasingly sensitive detectors, like high resolution and high speed cameras or fast A/D-converters that picked up from and drove ideas in the rapidly developing photonics field, together with

6426-400: The advantage lies in the proven high SNR detection technology, while swept laser sources achieve very small instantaneous bandwidths (linewidths) at very high frequencies (20–200 kHz). Drawbacks are the nonlinearities in the wavelength (especially at high scanning frequencies), the broadening of the linewidth at high frequencies and a high sensitivity to movements of the scanning geometry or

6545-527: The algorithm used. More recently, approaches that allow rapid single-shot imaging were developed to simultaneously capture multiple phase-shifted images required for reconstruction, using single camera. Single-shot time-domain OCM is limited only by the camera frame rate and available illumination. The "en-face" tomographic images are thus produced by a wide-field illumination, ensured by the Linnik configuration of

6664-525: The body of biological studies that use computer programming as part of their methodology, as well as a reference to specific analysis "pipelines" that are repeatedly used, particularly in the field of genomics. Common uses of bioinformatics include the identification of candidate genes and nucleotides (SNPs). Often, such identification is made with the aim of better understanding the genetic basis of disease, unique adaptations, desirable properties (esp. in agricultural species), or differences between populations. In

6783-402: The brain or feeding tube placement systems. For example, ENvizion Medical's ENvue, an electromagnetic navigation system for enteral feeding tube placement. The system uses an external field generator and several EM passive sensors enabling scaling of the display to the patient's body contour, and a real-time view of the feeding tube tip location and direction, which helps the medical staff ensure

6902-427: The coherence length of the light source. This interference is called autocorrelation in a symmetric interferometer (both arms have the same reflectivity), or cross-correlation in the common case. The envelope of this modulation changes as path length difference is varied, where the peak of the envelope corresponds to path length matching. The interference of two partially coherent light beams can be expressed in terms of

7021-540: The community. While some rehabilitation engineers have master's degrees in rehabilitation engineering, usually a subspecialty of Biomedical engineering, most rehabilitation engineers have an undergraduate or graduate degrees in biomedical engineering, mechanical engineering, or electrical engineering. A Portuguese university provides an undergraduate degree and a master's degree in Rehabilitation Engineering and Accessibility. Qualification to become

7140-500: The correct placement in the GI tract . Imaging technologies are often essential to medical diagnosis, and are typically the most complex equipment found in a hospital including: fluoroscopy , magnetic resonance imaging (MRI), nuclear medicine , positron emission tomography (PET), PET-CT scans , projection radiography such as X-rays and CT scans , tomography , ultrasound , optical microscopy , and electron microscopy . An implant

7259-446: The country-specific legislation, the main regulatory objectives coincide worldwide. For example, in the medical device regulations, a product must be: 1) safe and 2) effective and 3) for all the manufactured devices (why is this part deleted?) A product is safe if patients, users, and third parties do not run unacceptable risks of physical hazards (death, injuries, ...) in its intended use. Protective measures have to be introduced on

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7378-568: The design and verification of a wide range of home use and point of care medical devices along with other applicable standards in the IEC 60601 3rd edition series. The mandatory date for implementation of the EN European version of the standard is June 1, 2013. The US FDA requires the use of the standard on June 30, 2013, while Health Canada recently extended the required date from June 2012 to April 2013. The North American agencies will only require these standards for new device submissions, while

7497-470: The detection and diagnosis of cancer and precancerous lesions , such as Barrett's esophagus and esophageal dysplasia . The first use of OCT in dermatology dates back to 1997. Since then, OCT has been applied to the diagnosis of various skin lesions including carcinomas. However, the diagnosis of melanoma using conventional OCT is difficult, especially due to insufficient imaging resolution. Emerging high-resolution OCT techniques such as LC-OCT have

7616-422: The development of pharmaceutical drugs including biopharmaceuticals . Bioinformatics is an interdisciplinary field that develops methods and software tools for understanding biological data. As an interdisciplinary field of science, bioinformatics combines computer science, statistics, mathematics, and engineering to analyze and interpret biological data. Bioinformatics is considered both an umbrella term for

7735-430: The devices to reduce residual risks at an acceptable level if compared with the benefit derived from the use of it. A product is effective if it performs as specified by the manufacturer in the intended use. Effectiveness is achieved through clinical evaluation, compliance to performance standards or demonstrations of substantial equivalence with an already marketed device. The previous features have to be ensured for all

7854-408: The diagnosis and monitoring of retinal diseases, optic nerve diseases, and corneal diseases. It has greatly improved the management of the top three causes of blindness – macular degeneration , diabetic retinopathy , and glaucoma – thereby preventing vision loss in many patients. By 2016 OCT was estimated to be used in more than 30 million imaging procedures per year worldwide. OCT angioscopy

7973-469: The distance resolution and range were much longer than OCT. There are two types of FD-OCT – swept-source OCT (SS-OCT) and spectral-domain OCT (SD-OCT) – both of which acquire spectral interferograms which are then Fourier transformed to obtain an axial scan of reflectance amplitude versus depth. In SS-OCT, the spectral interferogram is acquired sequentially by tuning the wavelength of a laser light source. SD-OCT acquires spectral interferogram simultaneously in

8092-526: The documentation data and records supporting medical device certification. FDA technical file has similar content although organized in a different structure. The Quality System deliverables usually include procedures that ensure quality throughout all product life cycles. The same standard (ISO EN 13485) is usually applied for quality management systems in the US and worldwide. In the European Union, there are certifying entities named " Notified Bodies ", accredited by

8211-499: The fall-off is not a serious problem with the development of new generation CCD or photodiode array with a larger number of pixels. Synthetic array heterodyne detection offers another approach to this problem without the need for high dispersion. Swept-source OCT (Time-encoded frequency domain OCT) tries to combine some of the advantages of standard TD and spectral domain OCT. Here the spectral components are not encoded by spatial separation, but they are encoded in time. The spectrum

8330-497: The field. They may also feature extensive collaborative efforts with programs in other fields (such as the university's Medical School or other engineering divisions), owing again to the interdisciplinary nature of BME. M.S. and Ph.D. programs will typically require applicants to have an undergraduate degree in BME, or another engineering discipline (plus certain life science coursework), or life science (plus certain engineering coursework). Education in BME also varies greatly around

8449-400: The fields of dermatology and cosmetology. An imaging approach to temporal OCT was developed by Claude Boccara's team in 1998, with an acquisition of the images without beam scanning. In this technique called full-field OCT (FF-OCT), unlike other OCT techniques that acquire cross-sections of the sample, the images are here "en-face" i.e. like images of classical microscopy: orthogonal to

8568-472: The first time, not only manufacturers but also importers and distributors share a responsibility to ensure Electrical and Electronic Equipment within the scope of RoHS complies with the hazardous substances limits and have a CE mark on their products. The new International Standard IEC 60601 for home healthcare electro-medical devices defining the requirements for devices used in the home healthcare environment. IEC 60601-1-11 (2010) must now be incorporated into

8687-742: The form of implantable pills or drug-eluting stents . Artificial body part replacements are one of the many applications of bionics. Concerned with the intricate and thorough study of the properties and function of human body systems, bionics may be applied to solve some engineering problems. Careful study of the different functions and processes of the eyes, ears, and other organs paved the way for improved cameras, television, radio transmitters and receivers, and many other tools. In recent years biomedical sensors based in microwave technology have gained more attention. Different sensors can be manufactured for specific uses in both diagnosing and monitoring disease conditions, for example microwave sensors can be used as

8806-400: The former being an equivalent to the coherence length of the light source and the latter being a function of the optics. The axial resolution of OCT is defined as where λ 0 {\displaystyle \lambda _{0}} and Δ λ {\displaystyle \Delta \lambda } are respectively the central wavelength and the spectral width of

8925-416: The fourth can probe as deep as 500 micrometers, but with a lower (i.e. architectural) resolution (around 10 micrometers in lateral and a few micrometers in depth in ophthalmology, for instance, and 20 micrometers in lateral in endoscopy). OCT is based on low-coherence interferometry. In conventional interferometry with long coherence length (i.e., laser interferometry), interference of light occurs over

9044-489: The future development of prosthetics. For example, cognitive neural prosthetics (CNP) are being heavily researched and would allow for a chip implant to assist people who have prosthetics by providing signals to operate assistive devices. Pharmaceutical engineering is an interdisciplinary science that includes drug engineering, novel drug delivery and targeting, pharmaceutical technology, unit operations of Chemical Engineering , and Pharmaceutical Analysis. It may be deemed as

9163-426: The illumination line laterally. The focus is continuously adjusted during the scan of the sample depth, using a high numerical aperture (NA) microscope objective to image with high lateral resolution. By using a supercontinuum laser as a light source, a quasi-isotropic spatial resolution of ~ 1 μm is achieved at a central wavelength of ~ 800 nm. On the other hand, line illumination and detection, combined with

9282-731: The increasing availability of computing power were essential for its birth and success. In 1991, David Huang, then a student in James Fujimoto laboratory at Massachusetts Institute of Technology , working with Eric Swanson at the MIT Lincoln Laboratory and colleagues at the Harvard Medical School, successfully demonstrated imaging and called the new imaging modality "optical coherence tomography". Since then, OCT with micrometer axial resolution and below and cross-sectional imaging capabilities has become

9401-553: The institution's graduate or research programs, which have some tangible factors for rating, such as research funding and volume, publications and citations. With BME specifically, the ranking of a university's hospital and medical school can also be a significant factor in the perceived prestige of its BME department/program. Graduate education is a particularly important aspect in BME. While many engineering fields (such as mechanical or electrical engineering) do not need graduate-level training to obtain an entry-level job in their field,

9520-406: The interference envelope and carrier dependent on reference arm scan or time delay τ {\displaystyle \tau } , and whose recovery is of interest in OCT. Due to the coherence gating effect of OCT the complex degree of coherence is represented as a Gaussian function expressed as where Δ ν {\displaystyle \Delta \nu } represents

9639-566: The invention of OCT, Fujimoto, Huang, and Swanson received the 2023 Lasker-DeBakey Clinical Medical Research Award and the National Medal of Technology and Innovation. These developments have been reviewed in articles written for the general scientific and medical readership. It is particularly suited to ophthalmic applications and other tissue imaging requiring micrometer resolution and millimeter penetration depth. OCT has also been used for various art conservation projects, where it

9758-408: The item of interest. A cross-sectional tomogram ( B-scan ) may be achieved by laterally combining a series of these axial depth scans (A-scan). En face imaging at an acquired depth is possible depending on the imaging engine used. Optical coherence tomography (OCT) is a technique for obtaining sub-surface images of translucent or opaque materials at a resolution equivalent to a low-power microscope. It

9877-449: The last decades to respond to the many incidents caused by devices to patients. For example, from 2008 to 2011, in US, there were 119 FDA recalls of medical devices classified as class I. According to U.S. Food and Drug Administration (FDA), Class I recall is associated to "a situation in which there is a reasonable probability that the use of, or exposure to, a product will cause serious adverse health consequences or death" Regardless of

9996-434: The light beam of illumination. More precisely, interferometric images are created by a Michelson interferometer where the path length difference is varied by a fast electric component (usually a piezo mirror in the reference arm). These images acquired by a CCD camera are combined in post-treatment (or online) by the phase shift interferometry method, where usually 2 or 4 images per modulation period are acquired, depending on

10115-407: The light source. Fourier-domain (or Frequency-domain) OCT (FD-OCT) has speed and signal-to-noise ratio (SNR) advantages over time-domain OCT (TD-OCT) and has become the standard in the industry since 2006. The idea of using frequency modulation and coherent detection to obtain ranging information was already demonstrated in optical frequency domain reflectometry and laser radar in the 1980s, though

10234-412: The majority of BME positions do prefer or even require them. Since most BME-related professions involve scientific research, such as in pharmaceutical and medical device development, graduate education is almost a requirement (as undergraduate degrees typically do not involve sufficient research training and experience). This can be either a Masters or Doctoral level degree; while in certain specialties

10353-483: The manufactured items of the medical device. This requires that a quality system shall be in place for all the relevant entities and processes that may impact safety and effectiveness over the whole medical device lifecycle. The medical device engineering area is among the most heavily regulated fields of engineering, and practicing biomedical engineers must routinely consult and cooperate with regulatory law attorneys and other experts. The Food and Drug Administration (FDA)

10472-770: The maxillary molar, however, there is no difference with the current methods of dental operatory microscope. Research conducted in 2015 was successful in utilizing a smartphone as an OCT platform, although much work remains to be done before such a platform would be commercially viable. Photonic integrated circuits may be a promising option to miniaturized OCT. Similarly to integrated circuits silicon-based fabrication techniques can be used to produce miniaturized photonic systems. First in vivo human retinal imaging has been reported recently. In 3D microfabrication , OCT enables non-destructive testing and real-time inspection during additive manufacturing. Its high-resolution imaging detects defects, characterizes material properties and ensures

10591-426: The mirror in the reference arm, a reflectivity profile of the sample can be obtained (this is time domain OCT). Areas of the sample that reflect back a lot of light will create greater interference than areas that don't. Any light that is outside the short coherence length will not interfere. This reflectivity profile, called an A-scan , contains information about the spatial dimensions and location of structures within

10710-524: The national jurisdictional barriers that still exist. Recently, initiatives such as BIOMEDEA have sprung up to develop BME-related education and professional standards. Other countries, such as Australia, are recognizing and moving to correct deficiencies in their BME education. Also, as high technology endeavors are usually marks of developed nations, some areas of the world are prone to slower development in education, including in BME. Optical coherence tomography Optical coherence tomography ( OCT )

10829-443: The optic nerve. Retinal imaging with PS-OCT demonstrated how the thickness and birefringence of blood vessel wall tissue of healthy subjects could be quantified, in vivo. PS-OCT was subsequently applied to patients with diabetes and age-matched healthy subjects, and showed an almost 100% increase in vessel wall birefringence due to diabetes, without a significant change in vessel wall thickness. In patients with hypertension however,

10948-743: The orthodontic brackets using swept source OCT. Researchers have used OCT to produce detailed images of mice brains, through a "window" made of zirconia that has been modified to be transparent and implanted in the skull. Optical coherence tomography is also applicable and increasingly used in industrial applications , such as nondestructive testing (NDT), material thickness measurements, and in particular thin silicon wafers and compound semiconductor wafers thickness measurements surface roughness characterization, surface and cross-section imaging and volume loss measurements. OCT systems with feedback can be used to control manufacturing processes. With high speed data acquisition, and sub-micron resolution, OCT

11067-416: The past three decades, the speed of commercial clinical OCT systems has increased more than 1000-fold, doubling every three years and rivaling Moore's law of computer chip performance. Development of parallel image acquisition approaches such as line-field and full-field technology may allow the performance improvement trend to continue. OCT is most widely used in ophthalmology , in which it has transformed

11186-576: The potential to improve the clinical diagnostic process, allowing for the early detection of malignant skin tumors – including melanoma – and a reduction in the number of surgical excisions of benign lesions. Other promising areas of application include the imaging of lesions where excisions are hazardous or impossible and the guidance of surgical interventions through identification of tumor margins. Researchers in Tokyo medical and Dental University were able to detect enamel white spot lesions around and beneath

11305-604: The principles of physics, engineering, and biology to study the interaction of biological tissue and light, and how this can be exploited for sensing, imaging, and treatment. It has a wide range of applications, including optical imaging, microscopy, ophthalmoscopy, spectroscopy, and therapy. Examples of biomedical optics techniques and technologies include optical coherence tomography (OCT), fluorescence microscopy , confocal microscopy , and photodynamic therapy (PDT). OCT, for example, uses light to create high-resolution, three-dimensional images of internal structures, such as

11424-459: The production of new types of experimental mice such as the oncomouse (cancer mouse) for research. Neural engineering (also known as neuroengineering) is a discipline that uses engineering techniques to understand, repair, replace, or enhance neural systems. Neural engineers are uniquely qualified to solve design problems at the interface of living neural tissue and non-living constructs. Neural engineering can assist with numerous things, including

11543-476: The progression of the state of the art so as to redirect procurement patterns accordingly. Their inherent focus on practical implementation of technology has tended to keep them oriented more towards incremental -level redesigns and reconfigurations, as opposed to revolutionary research & development or ideas that would be many years from clinical adoption; however, there is a growing effort to expand this time-horizon over which clinical engineers can influence

11662-549: The reflectivity of the surface. The optical carrier is due to the Doppler effect resulting from scanning one arm of the interferometer, and the frequency of this modulation is controlled by the speed of scanning. Therefore, translating one arm of the interferometer has two functions; depth scanning and a Doppler-shifted optical carrier are accomplished by pathlength variation. In OCT, the Doppler-shifted optical carrier has

11781-701: The research and development of new devices for innovative therapies, treatments, patient monitoring, of complex diseases. Medical devices are regulated and classified (in the US) as follows (see also Regulation ): Medical/biomedical imaging is a major segment of medical devices . This area deals with enabling clinicians to directly or indirectly "view" things not visible in plain sight (such as due to their size, and/or location). This can involve utilizing ultrasound, magnetism, UV, radiology, and other means. Alternatively, navigation-guided equipment utilizes electromagnetic tracking technology, such as catheter placement into

11900-468: The retinal vessel wall thickness increased by 60% while the vessel wall birefringence dropped by 20%, on average. The large differences measured in healthy subjects and patients suggest that retinal measurements with PS-OCT could be used as a screening tool for hypertension and diabetes. OCT can used to measure the thickness of the Retinal nerve fiber layer (RNFL) . In the settings of cardiology, OCT

12019-415: The risk management file, the technical file, and the quality system deliveries. The risk management file is the first deliverable that conditions the following design and manufacturing steps. The risk management stage shall drive the product so that product risks are reduced at an acceptable level with respect to the benefits expected for the patients for the use of the device. The technical file contains all

12138-475: The sample using a translation stage, and using a novel micro-electro-mechanical system scanner. Line-field confocal optical coherence tomography (LC-OCT) is an imaging technique based on the principle of time-domain OCT with line illumination using a broadband laser and line detection using a line-scan camera. LC-OCT produces B-scans in real-time from multiple A-scans acquired in parallel. En face as well as three-dimensional images can also be obtained by scanning

12257-410: The sample (below the range of nanometers within successive frequency steps). Focusing the light beam to a point on the surface of the sample under test, and recombining the reflected light with the reference will yield an interferogram with sample information corresponding to a single A-scan (Z axis only). Scanning of the sample can be accomplished by either scanning the light on the sample, or by moving

12376-599: The sample under test. A linear scan will yield a two-dimensional data set corresponding to a cross-sectional image (X-Z axes scan), whereas an area scan achieves a three-dimensional data set corresponding to a volumetric image (X-Y-Z axes scan). Systems based on single point, confocal, or flying-spot time domain OCT, must scan the sample in two lateral dimensions and reconstruct a three-dimensional image using depth information obtained by coherence-gating through an axially scanning reference arm (Fig. 2). Two-dimensional lateral scanning has been electromechanically implemented by moving

12495-476: The scope of a biomedical engineer is the management of current medical equipment in hospitals while adhering to relevant industry standards. This involves procurement, routine testing, preventive maintenance, and making equipment recommendations, a role also known as a Biomedical Equipment Technician (BMET) or as a clinical engineer . Biomedical engineering has recently emerged as its own field of study, as compared to many other engineering fields. Such an evolution

12614-411: The sinc(z) behavior). Additionally, the dispersive elements in the spectroscopic detector usually do not distribute the light equally spaced in frequency on the detector, but mostly have an inverse dependence. Therefore, the signal has to be resampled before processing, which cannot take care of the difference in local (pixelwise) bandwidth, which results in further reduction of the signal quality. However,

12733-400: The source intensity, I S {\displaystyle I_{S}} , as where k 1 + k 2 < 1 {\displaystyle k_{1}+k_{2}<1} represents the interferometer beam splitting ratio, and γ ( τ ) {\displaystyle \gamma (\tau )} is called the complex degree of coherence, i.e.

12852-460: The spectral width of the source in the optical frequency domain, and ν 0 {\displaystyle \nu _{0}} is the centre optical frequency of the source. In equation (2), the Gaussian envelope is amplitude modulated by an optical carrier. The peak of this envelope represents the location of the microstructure of the sample under test, with an amplitude dependent on

12971-399: The structure and characteristics of target genes. Genetic engineering techniques have found success in numerous applications. Some examples include the improvement of crop technology ( not a medical application , but see biological systems engineering ), the manufacture of synthetic human insulin through the use of modified bacteria, the manufacture of erythropoietin in hamster ovary cells, and

13090-502: The trajectory of biomedical innovation. In their various roles, they form a "bridge" between the primary designers and the end-users, by combining the perspectives of being both close to the point-of-use, while also trained in product and process engineering. Clinical engineering departments will sometimes hire not just biomedical engineers, but also industrial/systems engineers to help address operations research/optimization, human factors, cost analysis, etc. Also, see safety engineering for

13209-433: The use of a high NA microscope objective, produce a confocal gate that prevents most scattered light that does not contribute to the signal from being detected by the camera. This confocal gate, which is absent in the full-field OCT technique, gives LC-OCT an advantage in terms of detection sensitivity and penetration in highly scattering media such as skin tissues. So far this technique has been used mainly for skin imaging in

13328-437: The vascular health of the retina via a technique called OCT angiography (OCTA). In ophthalmological surgery , especially retinal surgery, an OCT can be mounted on the microscope. Such a system is called an intraoperative OCT (iOCT) and provides support during the surgery with clinical benefits. Polarization-sensitive OCT was recently applied in the human retina to determine optical polarization properties of vessel walls near

13447-576: The widespread adoption of this imaging technology for coronary artery imaging. It is estimated that over 100,000 FD-OCT coronary imaging cases are performed yearly, and that the market is increasing by approximately 20% every year. Other developments of intracoronary OCT included the combination with other optical imaging modalities for multi-modality imaging. Intravascular OCT has been combined with near-infrared fluorescence molecular imaging (NIRF) to enhance its capability to detect molecular/functional and tissue morphological information simultaneously. In

13566-428: The world. By virtue of its extensive biotechnology sector, its numerous major universities, and relatively few internal barriers, the U.S. has progressed a great deal in its development of BME education and training opportunities. Europe, which also has a large biotechnology sector and an impressive education system, has encountered trouble in creating uniform standards as the European community attempts to supplant some of

13685-489: Was investigated in parallel by multiple groups worldwide since 1980s. Lending ideas from ultrasound imaging and merging the time-of-flight detection with optical interferometry to detect optical delays in the pico- and femtosecond range as known from the autocorrelator in the 1960's, the technique's development was and is tightly associated with the availability of novel electronic, mechanical and photonic abilities. Stemming from single lateral point low-coherence interferometry

13804-441: Was not designed for the tortuous cerebrovasculature encountered in the brain. However, despite these limitations, it showed the potential of OCT for the imaging of neurovascular disease. An intravascular OCT imaging catheter design tailored for use in tortuous neurovascular anatomy has been proposed in 2020. A first-in-human study using endovascular neuro OCT ( n OCT) has been reported in 2024. Endoscopic OCT has been applied to

13923-472: Was offered at University of Guelph as a four-year B.Eng. program. The Polytechnique in Montreal is also offering a bachelors's degree in biomedical engineering as is Flinders University. As with many degrees, the reputation and ranking of a program may factor into the desirability of a degree holder for either employment or graduate admission. The reputation of many undergraduate degrees is also linked to

14042-618: Was replaced and superseded by 2011/65/EU published in July 2011 and commonly known as RoHS 2. RoHS seeks to limit the dangerous substances in circulation in electronics products, in particular toxins and heavy metals, which are subsequently released into the environment when such devices are recycled. The scope of RoHS 2 is widened to include products previously excluded, such as medical devices and industrial equipment. In addition, manufacturers are now obliged to provide conformity risk assessments and test reports – or explain why they are lacking. For

14161-658: Was reported in 1997, by researchers in Fujimoto's laboratory at Massachusetts Institute of Technology. The first TD-OCT imaging catheter and system was commercialized by LightLab Imaging, Inc. , a company based in Massachusetts in 2006. The first FD-OCT imaging study was reported by Massachusetts General Hospital in 2008. Intracoronary FD-OCT was first introduced in the market in 2009 by LightLab Imaging, Inc. followed by Terumo Corporation in 2012 and by Gentuity LLC in 2020. The higher acquisition speed of FD-OCT enabled

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