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Wednesday January 19, 2005
The Diagnostic Potential of Airway Gas Analysis Using Cavity Ringdown Spectroscopy
Barbara Paldus, Ph.D. (Picarro Inc.)

Analysis of airway gases can potentially provide a sensitive real-time monitor of both lung and gastric functions, general physiological well-being, and of other conditions such as sedation or consciousness level while operating under anesthesia. Since different organisms metabolize substrates at different rates, often with isotopic and chiral discrimination, a species- and isotope-sensitive probe of airway gas could also be used as an early marker of bacterial or fungal infection.

Cavity Ringdown Spectroscopy (CRDS) is a novel ultra-trace gas sensing technology that is species specific, sensitive to isotopic substitution and intrinsically maintains high precision and absolute calibration. A laser is coupled into a stable optical cavity containing the gas (or liquid) to be analyzed, and is then decoupled rapidly. The decay time of the circulating power in the cavity, the "ring-down" time, is a very sensitive function of the losses within the cavity, and as such is an exceptionally good probe of absorption by the species in the cavity. Although the physical cavity length is on the order of a few tens of centimeters, effective path lengths of kilometers are routinely achieved. By continuously measuring ringdown times at the absorption peak and along the absorption feature baseline, absolute measurements may be made. The technique has the capability of monitoring biomarkers in quasi-real time at part-per-billion levels.

Barb will report on progress towards a compact, ruggedized cavity ringdown spectrometer to measure isotopes of carbon dioxide or trace amounts of ammonia and ethylene, all of which appear in the human breath, at the January 19th meeting of the IEEE Silicon Valley Chapter of the Engineering in Medicine and Biology Society. The spectrometer is currently fully contained in standard 19" rack mount enclosures and utilizes proven telecom-grade components for enhanced reliability. It is already in the field in industrial and research settings and has demonstrated a baseline noise level of 1X10-10cm-1/Hz1/2 over a wide range of ambient operating conditions, superior to all other competing optical spectroscopic techniques. Barb will also present results on typical instrument performance, including zero drift, precision, absolute accuracy, and linearity over the required operating concentration range for several industrial and medical applications.

Barbara Paldus is the CTO at Picarro and is responsible for technology strategy, research innovation, and business development. She leads the team that develops the company's breakthrough photonic technology. She has 14 awarded patents, 13 pending patent applications, and has published over 30 journal and conference papers, as well as two book chapters, on cavity ring-down spectroscopy (CRDS) and lasers. She has been recognized with 12 research and academic awards, most recently the Adolph Lomb Prize (2001) by the OSA. Barb received both her Ph.D. and M.S.E.E. degrees from Stanford University. She received her BS in electrical engineering and applied mathematics from the University of Waterloo, Canada.

Wednesday February 16, 2005
On-demand Technology Development for Medical Imaging Clinical Trials
Vivek Swarnakar, Vice President of Engineering, Synarc, Inc.

Slides in PDF format

Synarc is the world's largest central radiology service dedicated to clinical trials. Synarc provides services that integrate all aspects of the design and execution of clinical trials that use imaging and molecular markers across a spectrum of therapeutic areas including Arthritis, Cardiovascular, Neurology, Oncology, Orthopedics and Osteoporosis. Managing a clinical trial requires having the ability to efficiently and reliably support data collection, quality assurance, analysis, storage and retrieval. This is a multi-disciplinary effort that by design requires close collaboration of several business entities, hospitals and medical imaging sites. The requirements for implementing technical solutions for this industry are quite complex and often result in a development model that can be described as "on demand technology development". The on-demand aspect is driven by logistics and human processes natural to this industry. These include clinical trial end-point definition, ability to recruit patients for a clinical trial as well as monitoring safety of drugs. All development efforts have to be carried out in a manner where strict adherence to applicable regulatory guidelines is maintained at all times. In his talk, Dr Swarnakar, who heads the Engineering department at Synarc, will discuss typical challenges commonly encountered in developing technology for managing imaging based clinical trials on a global scale.

Vivek Swarnakar is the Vice President of Engineering at Synarc, where he is responsible for managing a team of about 60 engineers located in US and Europe and engaged in developing technology used to support clinical trials. Dr. Swarnakar has a Ph.D from the State University of New York at Buffalo, a Masters degree from the Rochester Institute of Technology and a BachelorŐs degree from the Universidade Federal da Paraiba, Campina Grande in Brazil, all in Electrical Engineering. He has published numerous peer-reviewed articles in the medical imaging area covering radiation-oncology, medical image compression, telemedicine and computer-aided detection (CAD). Dr. Swarnakar has over 20 years of software development experience in research and industrial settings. For the last 10 he has applied imaging technology and engineering principles to the medical field including work on a radiation therapy planning system, a digital mammography system and a computer aided breast cancer detection system. His research interests include fractals, neural networks, image analysis and compression. He has been an IEEE member for over 11 years.

Wednesday March 16, 2005
7:30pm in Clark Center Auditorium

Gastric Electrical Stimulation
Mir A. Imran
In-Cube, Inc.

One of the concepts proposed for the treatment of obesity is gastric electrical stimulation, also known as gastric pacing. Gastric pacing was first tried by Bilgutay in 1963. His concept was to take the idea of cardiac pacing and deliver an electrical stimulus to the stomach. The stomach has an intrinsic electrical pacemaker similar to that of the heart. However, the natural electrical rhythm of the stomach is three cycles per minute which is much slower than the heart. The pacemaker region is located in the proximal gastric corpus near the greater curvature. Electrical signals, also called slow waves propagate from the pacemaker region proximally to the pylorus distally. Stomach contractions and subsequent emptying depend on normal gastric electrical slow waves. Examples of gastric electrical abnormalities include: tachygastria, bradygastria, and electrical-mechanical dissociation. Patients that exhibit these abnormal electrical rhythms have delayed gastric emptying, nausea, weight loss, early satiety, and fullness as common signs and symptoms. Examples, of these types of diseases include gastroparesis and gastric ectopic pacemakers.

Over the last four decades, considerable research with the use of gastric and intestinal pacing has been performed in animals and humans. Specific pacing parameters, consisting of amplitude, pulse type and duration and pacing frequency have been defined to demonstrate that the gastric intrinsic slow wave can be entrained or disrupted. The procedure of pacing the gastrointestinal tract for the treatment of obesity and gastroparesis has proven safe and effective in multiple human trials.

The ability to manipulate the myoelectrical activity of the stomach has become a research focus in the treatment of obesity as a way to create a sense of fullness and satiety by inducing a number of physiological changes including changes in satiation hormones such as grhelin, delaying gastric emptying, inducing gastric retro-contractions, disrupting the normal slow wave, and changing gastric tone. Gastric electrical stimulation provides an advantage as an obesity treatment because it does not permanently alter the gastric anatomy such as that seen with other more invasive surgical procedures.

Although the concept of gastric electrical stimulation has been used in medicine for over 30 years to treat various motility disorders, is has seen a renewed interest for the treatment of obesity over the last ten years. Gastric electrical stimulation provides an exciting alternative to current invasive surgical procedures for the treatment of obesity and other gastrointestinal motility disorders.

Mr. Imran is recognized for his history as a scientist, inventor, entrepreneur and investor of medical technology companies. He is the founder and Chairman of InCube Laboratories, Inc. (, research laboratories and business incubator for medical and technology companies. Through InCube, and prior to its establishment, he founded numerous medical and high technology companies. Mr. Imran currently serves as a Director for CardioVasc, Inc., Zonare, Inc., Intrapace, Inc., Entrack, Inc., SafeView, Inc., Bodymedia, Inc., EGeen Inc. Acumen Medical Inc., Python Medical, Inc. and Neurolinks, Inc. He was a pioneer in the development of the automatic implantable defibrillator, a device that has saved hundreds of thousands of lives, and has become a standard of care in cardiology. One of his high profile medical inventions is his EEG monitoring sensor array that John Glenn was featured as wearing in the Time Magazine story of his latest space mission. This became the core product for Physiometrix and has become a standard diagnostic tool used in neurophysiology. In 1992, Mr. Imran invented a cooled RF ablation catheter for the treatment of ventricular arrhythmias. This invention became the initial product of Cardiac Pathways, and is now widely used by cardiac electro-physiologists. In 1995, he developed a low-pressure balloon and aspirator system for use in catheter based interventions. Mr. Imran was the first to articulate the concept of distal protection during high-risk interventions. Mr. Imran's device became the primary innovation for Percusurge, which was acquired by Medtronic in December 2000. In the medical field Mr. Imran's interest is to develop medical devices that blur the distinction between organic and synthetic and advance patient treatment options.

Mr. Imran's current research interests include tissue engineering, gastroenterology, nephrology, neurology, orthopedics, congestive heart failure and artificial organs.

Mr. Imran is an active angel investor and a limited partner in several venture funds. In addition, he serves as an Advisor to and Alley Ventures and is a Venture Partner and an Advisor of DFJ ePlanet Ventures, a $650 million global venture capital fund, based in Silicon Valley.

Mr. Imran's formal education consists of a B.S. in electrical engineering and M.S. in Bioengineering from Rutgers University. After three years at the Rutgers Medical School, which included research in bioengineering, he pursued his subsequent interests in industry, which include the establishment of close to 200 patents in his name, and numerous scientific publications.

Wednesday April 20, 2005
7:30pm in Clark Center Auditorium
Optional dinner at 6:15pm in Stanford Hospital Cafeteria

Tactile Pressure Imaging: A New Tool For In Vivo Physiological Assessment
As Applied To Gastroenterology
Tom Parks, Ph.D.
Sierra Scientific Instruments, Inc.

Gastroenterological motility disorders are significant both in terms of their impact on public health and demand on health care resources. More than 40 million Americans suffer from conditions that include gastroesophageal reflux disease (GERD), achalasia, dysphagia, incontinence, and pelvic floor dysfunctions. SSI has developed advanced pressure imaging systems with proprietary transducers to provide high fidelity pressure maps of the Gastrointestinal (GI) tract. This dramatically improves diagnostic clarity and simplifies clinical procedures when compared to existing technology.

Sierra has completed clinical validation, received FDA 510(k) clearance, and begun commercial production of its first product, the ManoScan(TM) motility visualization system. This technology was initially developed under NIH funding and is receiving enthusiastic support by experts and clinicians alike. It provides an order of magnitude more pressure transducers (i.e. increased resolution) than current technology to enable novel visualization of gastrointestinal motility physiology (the movement of contents through the GI tract). In this talk operating principles and features of this technology will be discussed; furthermore, developments underway for the next generation device with an additional order of magnitude increase in resolution will be described. A portable version of the device showing real-time pressure data collection and imaging will be demonstrated, and pressure image videos of clinical case studies of normal and pathological conditions will be shown.

Tom Parks led the development of the ManoScan device and has been CEO of Sierra Scientific Instruments since 2003. He has more than 20 years of experience in technology development, corporate management, and entrepreneurial business. Dr. Parks has led teams of scientists and engineers in research and development initiatives involving aerospace sensors, control systems, and medical products. He founded and grew a sustained business producing engineering laboratory workstations. These systems are considered to be the standard in excellence in their field and are in use in over 400 universities world-wide. He has served as Senior Scientist and line manager for a major aerospace firm with oversight of an organization with a $30M annual budget. Dr. Parks received his Ph.D. from the University of Southern California in mechanical engineering and control systems. He has received numerous academic and technical achievement awards and has 11 patents issued and pending.

Wednesday, May 18, 2005
7:30pm in Clark Center Auditorium
Optional dinner at 6:15pm in Stanford Hospital Cafeteria

Architecture and Application of Wireless Communication
In Glucose Monitoring for People with Diabetes
Charles Nelson, Director of Engineering, Abbott Diabetes Care

Diabetes mellitus, a disease in which the pancreas fails to produce insulin or cells fail to respond to insulin for cellular metabolism of glucose, is a world-wide public health problem in terms of loss of quality of life and corresponding cost of care.

There are over 140 million people with diabetes worldwide, including 18-20 million in the USA. This number is increasing and expected to double by 2030. Approximately 12-14 million diabetics are classified as noninsulin dependent, or Type II, diabetics who can control their glucose levels by changes in life style by the use of medication or by the infrequent use of insulin. For approximately 1-3 million diabetics classified as Type I diabetics, injections of insulin are needed to maintain glucose levels. Data from the Diabetes Control and Complications Trial (DCCT), reported in 1993, show that the quality of life may significantly be improved for people with diabetes if good control of blood sugar (glucose) levels is maintained. Thus, there is a need for frequent and accurate self-testing of glucose.

Diabetes has both chronic and acute morbidity associated with this disease. Chronically elevated blood sugar levels are know to cause blindness, neuropathy, vein necrosis of the extremities, kidney failure, and contribute to heart disease. Acute cases of hypoglycemia, low blood sugar, can cause death. American Diabetes Association estimated in 1997 that the combined health care costs of diabetes management and the co-morbidities related to diabetes in the United States was $98 billion annually. In 1997, the ADA estimated that a person with diabetes spent $10,071 on health care vs. 2669 for a person without diabetes. These costs are growing 10 to 15% annually in developed nations. Therefore, the combined global estimates for the cost of this disease to society is $200 to $350 billion in 2004.

At Abbott Diabetes Care, formally Therasense, our mission is to improve the quality of lives for our customers through technologically advanced and high quality products. As part of our initiative in diabetes disease management, design and commercialization of cost effective electromechanical solutions is paramount to improve the lives of our customers.

Two Abbott Diabetes Care solution exist that employ wireless data transfer from biosensors to the information technology (IT) infrastructure. One, of these solutions is for discrete glucose whereas the other is for continuous glucose. The discrete glucose meter acts as a pico server and takes the data generated by a blood glucose measurement and send it to another device in the personal area network (PAN) of the user. The continuous glucose meter employs two wireless linkages. The first from the biosensor to the pico server and the second from the pico server to the IT infrastructure.

Our discrete and continuous glucose monitors utilize complicated but elegant application of structured C+ state machines and microprocessors. Our most advanced product, Navigator, employs a novel CPU architecture that improves the function, flexibility, and time to market. One part of the architecture is communication. We have begun to broadly utilize the 802.15 standard and BlueTooth protocol as a cable replacement and PAN linkage.

The novel CPU architecture affords specialization in the function of each module around the most intensive tasks. By breaking the architecture into discrete function based modules, the most appropriate microprocessor, speed, power consumption, and interfaces may be designed. In our design the functions are broken along the lines of duty cycle and job functions. The first module retrieves all of the data and performs the data reduction. The second module manages the user interface. The third module manages the communication link. All of the modules communicate through an internal bus.

The communication to the IT infrastructure utilizes the BlueTooth protocol and commercially available ARM7 based modules. BlueTooth has received broad acceptance in the consumer electronics space for personal information management, audio data transfer (files and streaming music), device interoperability (phone to computer user interface for dial up), and data transfer. BlueTooth provides the ideal linkage for diabetes management within the personal area network. It is robust, secure, and standard. This allows communication into the burgeoning PAN and machine interactions of the user. The BlueTooth link has been approved by FDA and is a recognized standard, certified protocol globally.

As we look into the future, our bodies will reach new levels of longevity through the application of today's technologies. At Abbott Diabetes Care, we are realizing a small subset of these technologies with future implications for disease management. Evolution of biosensors and their connectivity to our personal area networks and machine interfaces will provide real time and essential feedback on our state of health. Armed with this information, debilitating co-morbidities associated with diabetes will be substantially reduced. Acute morbidity related to diabetes can be reduced or eliminated through user intervention in the response to continuous health status data. As technologist, we have the great opportunity to help the people of society that have no choice, people with debilitating diseases such as diabetes.

Mr. Charles L. Nelson is currently the Director of Engineering for Abbott Diabetes Care, a Division of Abbott Laboratories. Charles has over 20 years of experience commercializing medical technology in the areas of diagnostics, orthopedics, and cardiovascular products. Charles graduated from Purdue University with a Bachelor of Science in Chemical Engineering and holds a Master of Science degree from Northwestern University. Charles is inventor or co-inventor on over 11 issued patents and several pending applications. The engineering team at Therasense launched the Freestyle Flash glucose meter in 2003. This product grew to over $100 million in sales in 2004. Recently, the first commercial design for Navigator, the continuous glucose monitor, was completed.

Wednesday, June 15, 2005
7:30pm in Clark Center Auditorium
Optional dinner at 6:15pm in Stanford Hospital Cafeteria

A Pendant-Geometry CT Scanner for Breast Cancer Detection:
Design, Characterization and Initial Clinical Assessment
John M. Boone, Ph.D.
UC Davis

The purpose of this investigation was to characterize the performance of a cone-beam CT scanner system custom designed for breast imaging. The breast CT scanner was designed and fabricated using an end-windowed industrial x-ray source and a 30 cm x 40 cm CSI thin-film transistor (TFT) flat-panel x-ray detector. The first prototype scanner (Albion) utilizes 360 acquisitions of 1,000 projection images (768 x 1024) over a 33 second acquisition. The 88 cm source to detector distance and the 48 cm source to isocenter distance allow breasts from 10 cm to 18 cm in diameter to be scanned, and the size-dependent technique factors were determined to allow scanning at the same average glandular dose levels as two-view mammography.

The spatial resolution was characterized using a thin tungsten wire, and the contrast resolution was evaluated using low contrast test objects. Scattered radiation levels were measured as a function of breast diameter, beam energy, and breast composition. The spatial resolution is characterized by a modulation transfer function with 10% modulation at approximately 1.2 inverse millimeters. Contrast resolution was found to be dependent upon breast diameter in the size of the test object in question. Scatter to primary ratio (SPR) at the center of the field of view were measured as 0.25, 0.50, and 0.92 for 50%/50% breast phantoms of 10 cm, 14 cm, and 18 cm in diameter, respectively.

While a number of artifacts proved difficult to remove, the image quality of the scanner based upon its technical performance and subjective analysis of cadaver breast images suggests that the Albion prototype is capable of good performance. A number of technical details in the design of the scanner will be discussed, including the x-ray tube assembly (bow-tie filter and x-ray shutter), rotating gantry system, etc. Validated Monte Carlo techniques were used to assess the average glandular dose of the breast, based upon inferred spectral measurements. Clinical evaluation of the breast CT scanner on volunteers and patients will begin shortly, with initial results should be available in March 2005.

John M. Boone, Ph.D., received his undergraduate degree in medical physics from UC Berkeley, and graduate degrees in Radiological Sciences from UC Irvine. After faculty positions at the University of Missouri and Thomas Jefferson University (in Philadelphia), Dr. Boone joined the faculty at UC Davis in 1992. Dr. Boone is currently Professor and Vice Chairman of Radiology (for Research) and Professor of Biomedical Engineering at UC Davis. His is certified by the American Board of Radiology in Radiological Physics, is a fellow of the American Association of Physicists in Medicine and of the Society of Breast Imaging, and won an Outstanding Achievement Award in the Society for Photo-optical and Instrumentation Engineers. Dr. Boone's research interests include the development of a dedicated CT scanner for early breast cancer detection, Monte Carlo evaluation of image quality and radiation dose, and the development of mouse imaging technology combining x-ray and gamma-ray imaging.

Wednesday, September 21, 2005
Computer-aided Detection in Diagnostic Imaging
Sandra Stapleton

Computer-aided detection (CAD) techniques have been under investigation for nearly two decades, with most initial work aimed at helping radiologists detect breast cancer with mammography. This pioneering work focusing on CAD as a "detection" aid for mammography has led to the commercialization of several mammography CAD systems and the adoption of CAD by a large number of hospitals and breast centers -- over 2000 mammography CAD systems are in clinical use today. More recently, CAD systems have been developed for other clinical applications, including colon and thoracic analysis packages. With the development of these and other new CAD applications, CAD is evolving from a "detection" aid that provides a second opinion, to a tool integral to the clinical review process.

Using mammography CAD as a case study, Ms Stapleton will present an overview of CAD technology and the path to commercializing a CAD application, followed by a discussion of new CAD applications and their application to improving the decision making process across the clinical enterprise.

Sandra Stapleton is currently working as a consultant developing technology and business development strategies for emerging CAD companies. Previously she was Vice President of Technology at R2 Technology, Inc., the company which developed and commercialized the first CAD systems for mammography and thoracic computed tomography (CT). More recently, she was Senior Vice President of Business Development for Medicsight, an emerging CAD company which obtained the first FDA clearance for a colon CAD product. Ms Stapleton has a Masters Degree in Medical Biophysics from the University of Toronto, Canada, where her graduate work focused on using computational analysis to quantify brain deficits due to stroke and dementia as seen on single photon emission computed tomography (SPECT) scans.

Wednesday, October 19, 2005
Neural basis of reach preparation and communication prosthetics
Krishna Shenoy
Department of Electrical Engineering & Neurosciences Program
Stanford University

Our seemingly effortless ability to reach out and swat a fly or grab a cup belies the sophisticated neural computations at work in our nervous system. It has long been recognized that, before moving, we somehow prepare neural activity such that, when called upon, the desired movement unfolds. But the goals of movement preparation and the underlying neural mechanisms remain poorly understood. I will describe our recent electrophysiological investigations of how cerebral (pre-motor) cortex prepares and helps execute movements. Our results suggest that the brain is attempting to optimize preparatory neural activity and can delay movement until this activity is sufficiently accurate.

With an increased understanding of movement planning, it is also possible to design real-time electronic systems capable of translating neural plans into prosthetic movements. I will also describe our recent electrophysiological investigations aimed at establishing the fundamental, neurobiologically dictated performance limits of communication prostheses. Our results suggest that at least a factor of four performance improvement is possible, which is essential for starting to assess the potential benefits of clinical cortically-controlled prosthetic systems.

Professor Shenoy heads the Neural Prosthetic Systems Laboratory at Stanford University. His research group conducts neuroscience (systems & cognitive neuroscience) and neuroengineering (electrical, bio, and biomedical engineering) research. The group investigates the neural basis of sensorimotor integration and coordination, and designs neural prosthetic systems to assist disabled patients. Professor Shenoy teaches EE101B Circuits II and EE418 Topics in Neuroengineering.

Professor Shenoy received the B.S. degree in Electrical Engineering from the University of California at Irvine in 1990 (Summa Cum Laude), the S.M. degree in Electrical Engineering from MIT in 1992, and the Ph.D. degree in Electrical Engineering from MIT in 1995. He was a postdoctoral fellow in the Division of Biology at Caltech from 1995-2001. In 2001 Professor Shenoy joined the Department of Electrical Engineering at Stanford University, where he is also a member of the Neurosciences Program (School of Medicine) and is affiliated with Stanford's Bio-X Program, Biodesign Program, and NIS (Neurosciences Institute at Stanford). Honors and awards include NSF and Hertz Foundation graduate fellowships, the 1996 Hertz Foundation Doctoral Thesis Prize, an NIH postdoctoral fellowship, a Burroughs Wellcome Fund Career Award in the Biomedical Sciences, the William George Hoover Faculty Scholar in Electrical Engineering at Stanford University, the Robert N. Noyce Family Scholar in the Stanford University School of Engineering, an Alfred P. Sloan Research Fellowship, and Defense Sciences Research Council (DSRC/DARPA) fellow and member. Dr. Shenoy is a member of the IEEE (Engineering in Medicine and Biology Society, EMBS), Eta Kappa Nu, Tau Beta Pi, Society for Neuroscience and Neural Control of Movement Society.

Wednesday, November 16, 2005
High Frequency Ultrasound Imaging of the Anterior Segment of the Eye:
Imaging Schlemm's Canal for Diagnosis and Surgical Guidance
Stan Conston, Founder and VP of Research
substituting for Ron Yamamoto, Chief Scientific Officer, and Director
iScience Surgical Corp.

A new, high-frequency (80 MHz) ultrasound imaging system (iView) for in-vivo intra-operative visualization of anterior microstructures of the eye, and its application in Schlemm's canal for glaucoma management, will be described.

Non-invasive medical imaging of the eye typically involves B mode ultrasound imaging at frequencies of 10 to 30 MHz for general imaging of the macroscopic structures, or an ultrasound biomicroscope (UBM) operating at 50 MHz for higher resolution. More recently, optical coherence tomography (OCT) has been used to image the posterior retina regions of the eye at very high resolution. However, none of the existing imaging systems for the eye are useful in imaging Schlemm's canal of the eye, an approximately 150 micron diameter channel for aqueous humor involved in glaucoma that is in the front of the eye. Also the existing imaging systems are not designed for intra-operative use to guide surgery.

iScience Surgical Corporation and collaborators have developed an ultrasound imaging system operating at a center frequency of approximately 80 MHz to visualize Schlemm's canal. The imaging system utilizes a mechanically scanned high frequency transducer coupled to a PC with software to control the transducer motion, RF and display the image. The handpiece housing the transducer incorporates a replaceable sterile interface to allow images to be taken in the operating room to assess patient anatomy and to guide microsurgery. In particular, the imaging system is currently being used to guide a micro-catheter developed by iScience Surgical to perform minimally invasive surgery of the eye.

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