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With major advances in MEMS and nanotechnology and their proliferation into medicine, it is important to have a working knowledge of the critical steps in obtaining U.S. Food and Drug Administration (FDA) approval for commercialization. An understanding of the core elements and expedited review opportunities for medical devices provides entrepreneurs a key advantage in decision making, development and commercialization for the shortest time to market.
Many MEMS products intended for use with humans are considered medical
devices under the FDA approval process. This includes products for
diagnostics, monitoring, surgical and therapeutic applications. For a
manufacturer to market or commercially distribute a medical device, it
must first comply with the regulatory requirements of the FDA. The
critical steps of this process are outlined in the flow chart below.
Integrated Sensing Systems, Inc. (ISSYS) and the University of Michigan announced that they have received a $1.5 million National Institute of Health (NIH) grant titled "Novel Micro-Implant To Measure Intracardiac Pressure In Congenital Heart Patients." Dr. Martin Bocks, a pediatric cardiologist at the University of Michigan and the project's medical principal investigator, stated that "we are extremely excited to continue working with ISSYS to develop a wireless, implantable pressure sensor for our patients with complex forms of congenital heart disease. This pressure sensing implant has the potential to greatly improve the care we provide to our most complex patients and will provide us with unprecedented opportunities to learn more about their unique physiology."
Two common types of hearing loss suffered by millions of people worldwide are sensorineural hearing loss and conductive hearing loss. The former is caused primarily by damage to the cochlea, the snail-shell like structure of the inner ear containing hair cells, the movement of which is interpreted by the brain as sound. On the other hand, conductive hearing loss relates to problems with conducting sound waves along the route between the outer ear to the middle ear, and may occur along with sensorineural hearing loss. This article examines MEMS based approaches to improving the ability to hear.
Bio-Rad Laboratories, a manufacturer and distributor of life science research and clinical diagnostics products, announced this week that it has acquired QuantaLife, a microfluidic technology startup, for $162 million in cash plus potential future milestone payments. QuantaLife raised $17.2 million in venture capital financing in December 2010.
PerkinElmer, a global biomedical company, announced this week that it has signed a definitive agreement to acquire Caliper Life Sciences, a Hopkinton, Massachusetts-based firm that specializes in microfluidic technologies for life sciences research, diagnostics and environmental markets, for a total net purchase price of approximately $600 million in cash. The total purchase price represents a premium of 42% for Caliper Life Sciences shareholders. "The acquisition of Caliper Life Sciences brings innovative molecular imaging and detection technologies to our portfolio, complementing our world-leading offerings in life science, diagnostics, environmental and food markets," said PerkinElmer's CEO Robert F. Friel.
Firefly BioWorks, a manufacturer of cancer diagnostic assays based on microfluidics, announced this week that it was awarded a $2 million grant from the National Cancer Institute for microRNA profiling. MicroRNAs are an emerging class of biomarkers that are proving to be important indicators for early diagnosis of cancer and other diseases. The company will use the award to expand production capacity and validate its microRNA assay against the current state of the art. The goal of the Phase II SBIR grant studies is to develop a product providing a combination of performance, throughput and cost not available from existing solutions.
They may look and act like natural human cell membranes but the synthetic cell membranes invented by A*STAR's IMRE have more advantages. IMRE's patented synthetic cell membranes can be made-to-order, are easier to maintain in a laboratory environment and do not require the lengthy preparation that comes with working on live cell membranes. The synthetic cell membranes mimic the natural functions of cell membranes, such as interacting with drug molecules and antibodies, which is crucial in the drug discovery process. The innovation also provides a more stable membrane model for a better understanding of the mechanisms of diseases that affect human cells.
Dr. Greg Galvin is a successful veteran of the MEMS industry. His first company was sold in 2000 to Calient Networks, an optical MEMS switching company in San Jose. The transaction at the time was valued at ~$300 million in cash and stock. Dr. Galvin's second company, Kionix, focuses on the design and fabrication of MEMS inertial sensing devices and was acquired in 2009 by ROHM Co., Ltd. for $233.5 million. Now, Dr. Galvin has launched his third company, Rheonix, that concentrates on molecular diagnostics applications enabled by microfluidic technologies. In this extensive interview, Dr. Galvin discusses opportunities in the molecular diagnostics market, current cost trends and technology developments, and shares the vision for his new company.
Valencell, a startup company based in North Carolina that is focused on mobile health and fitness technologies, announced this week that that it has received $5.5 million in venture capital funding. The round was led by Best Buy Capital, the investment group of Best Buy, with participation from previous investors TDF and True Ventures. Valencell is the creator of powered earbuds which give audio headsets the ability to monitor the health and fitness of the user. The company's sensor technology tracks real-time physiological metrics including heart rate, calories burned, steps taken, distance traveled, speed and more, while the consumer listens to music, talks over the phone, or goes about daily life activities. Data is streamed to smartphones or music players through wired or wireless links, enabling live body metrics, training, and coaching via fitness applications on mobile devices and online.
Retinal disease, or degeneration of the retinal cells, is exemplified by genetically caused retinitis pigmentosa (RP) and age-related macular degeneration (MD). These are leading causes of blindness affecting an estimated 1-3 million and 25-30 million people worldwide, respectively. As MD progresses, the tissue of the macula is destroyed leading to a complete loss of vision in the center. In the case of RP, early symptoms include night blindness, loss of contrast and steadily diminishing peripheral vision. Both can be traced to degenerating light-sensitive rods and cones in the retina.
