• Weekly Vitals: IOM Reviews the 510(k) Process, VCs Like Life Sciences, and More

    It seemed like the medical device industry had only one thing on its mind this week: the evaluation of the 510(k) clearance process by the  Institute of Medicine (IOM).  Although the report was only released today, some industry professionals made a preemptive strike to discredit the report as biased earlier in the week. As expected, the IOM's report recommended revisions to the process: "The committee finds that the current 510(k) process is flawed based on its legislative foundation...
  • MIT Team Grows Electronic Components in Water

    A new way to produce entire electronic devices through a liquid-based process has been developed by a team of researchers at Massachusetts Institute of Technology (MIT; Cambridge, MA), which eliminates the need for expensive semiconductor manufacturing facilities and processes. The new technique is called hydrothermal synthesis, which essentially uses a syringe to push solution through a capillary tube one-tenth of a millimeter wide to produce a functional light-emitting diode (LED) array made...
  • Scientists Exploit Piezoelectric Nanowire Devices to Form New Type of Memory

    Researchers at the Georgia Institute of Technology (Georgia Tech; Atlanta) are exploiting the properties of zinc oxide nanowires to develop a new type of piezoelectric resistive switching device in which the write-read access of memory cells is controlled by electromechanical modulation. Operating on flexible substrates, arrays of these devices could provide a new way to interface the mechanical actions of the biological world to conventional electronic circuitry.An array of piezoelectrically...
  • Healthy Growth Predicted for Diagnostic Imaging Market

    The future is looking bright for the global diagnostic imaging market. Thanks to an aging population and expanding uses of diagnostic imaging, the sector is expected to increase from $20.7 billion in 2010 to $26.6 billion by 2016, according to the recently released marketsandmarkets.com report, "Diagnostics Imaging Market: Competitive Landscape and Global Forecasts 2010–2016."Leading the diagnostic imaging market in 2010 was x-ray technology, obtaining a 34% share in 2010, the report states....
  • Pee-Ew! Scientists Create Carbon Nanotube–Based Sensor with a Sense of Smell

    In the quest to integrate biological molecules with nanotechnology, a group of researchers at the University of Pennsylvania (Philadelphia), University of Miami, University of Illinois at Urbana-Champaign, Princeton University (Princeton, NJ), the Monell Chemical Senses Center (Philadelphia), Evolved Machines (Palo Alto, CA), and Nanosense Inc. (Redwood City, CA) have developed a a carbon nanotube–based transistor that incorporates olfactory receptor proteins (ORs). Seeking to create electronic...
  • Weekly Vitals: FDA on Medical Mobile Apps, Industry Groups Rally Against Device Tax, and More

    Among the biggest stories breaking this past week was FDA's announcement that it is seeking input on its proposed oversight approach for select mobile medical apps. "The use of mobile medical apps on smart phones and tablets is revolutionizing health care delivery," said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. "Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they...
  • Fort Wayne Metals Trademarks Damage-Resistant Wire for Implantable Devices

    Metal before (top) and after (bottom) NDR treatment.In response to the increasing challenge of engineering adequate strength into wire as implantable medical devices shrink, Fort Wayne Metals Research Products Corp. (Fort Wayne, IN) has gained trademark registration for its Nanograin damage-resistant (NDR) material refinement process. Developed to maintain fatigue strength in small-diameter wires used in critical implant applications, the NDR technique is a thermal-mechanical process that...
  • Going Mobile—But Not so Fast, Says FDA

    In a variety of blogs and articles, MPMN has covered the brave new world of mobile and wireless medical device applications. Using a smartphone or other mobile computing devices, both patients and doctors alike will be able to keep tabs immediately on a range of bodily and device functions, from calorie intake and glucose levels to implantable device performance and drug delivery.But FDA is saying "hold your horses," announcing that it is seeking input on its proposed oversight approach for...
  • Swedish Surgeons Implant Artificial Trachea

    Surgeons at Karolinska University Hospital (Huddinge, Stockholm) have transplanted a fully synthetic, tissue-engineered trachea into a man with late-stage tracheal cancer. The trachea scaffold was built by scientists led by Alexander Seifalian, professor of nanotechnology and regenerative medicine at University College London.An artificial human trachea implanted in a patient in Sweden is composed of a polymer covered by stem cells derived from the patient's bone marrow.The scaffold was...
  • America's Most Implanted Devices

    The U.S. medical implant market was valued at $32.3 billion in 2010, according to global consultancy Frost & Sullivan. To find out which devices were leading the pack in terms of actual use, the team at 24/7 Wall St. dug through National Health Survey data, professional physician services, peer-reviewed journals, and SEC filings to compile a list of the eleven most implanted medical devices in America. And the results and rankings on the list may just surprise you.Pacemakers are the ninth...
  • Weekly Vitals: Risky Pelvic Mesh, Rebounding from Healthcare Reform, and More

    It was another eventful week in the medical device industry. Drawing a lot of attention this week was the announcement by FDA that surgical meshes designed to treat pelvic prolapse in women may expose patients to unnecessary risks. Also making news this week was a tiny lensless camera that fits on the head of a pin developed by researchers at Cornell University that could someday be employed in surgical applications or as part of an implanted imaging system. Furthermore, our sister publication...
  • Cornell Scientists Give a Jolt to Defibrillator Design

    Clear the way for a lower-energy, potentially safer method of defibrillation. Scientists at Cornell University (Ithaca, NY) have developed a new approach to treating atrial fibrillations and other cardiac arrhythmias dubbed low-energy antifibrillation pacing (LEAP) that, unlike conventional defibrillation, does not damage surrounding tissue.Correction of a potentially dangerous fibrillation has historically been achieved through the use of a defibrillator, which produces large electrical pulses...
  • Soft and Mushy: Meet the New Generation of Biocompatible Memory Devices

    In a move that opens the door to a new generation of biocompatible electronic devices, researchers from North Carolina State University (NC State; Raleigh) have developed a memory device that is soft and functions well in wet environments. “We’ve created a memory device with the physical properties of Jell-O,” remarks Michael Dickey, an assistant professor of chemical and biomolecular engineering at NC State and coauthor of a paper describing the research.A memory device with the physical...
  • Ironing the Wrinkles Out of Graphene

    Over the past few years, graphene has been hailed for its potential uses in such wide-ranging medical device applications as antimicrobial technologies and electronics. Indeed, graphene's electrical capabilities have been heralded far and wide, not least in blogs and editorials featured in Medical Product Manufacturing News. as "Graphene-Based Paper Demonstrates Antibacterial Properties," "Graphene Arrays Could Revolutionize Electronics," and "Going Gaga Over Graphene."A map showing the...
  • High-Resolution MicroOCT Imaging Technology May Improve Diagnosis, Treatment of Coronary Artery Disease

    Developed by researchers at the Center for Photomedicine at Massachusetts General Hospital (MGH), a 1-µm-resolution version of the intravascular imaging technology optical coherence tomography (OCT) provides a resolution that is 10 times greater than that of standard OCT. This high-resolution tissue-imaging technology allows for the evaluation of cellular and subcellular features of coronary artery disease, which could someday assist in better diagnosis and treatment of the condition.Offering...
  • Antimicrobial Technology for Textiles, Medical Devices Combats HAIs

    As hospital-acquired infections come under increasing scrutiny, scientists are attempting to develop a range of materials with antimicrobial properties. Among them is Jason Locklin, a researcher at the University of Georgia (UGA; Athens), who has invented a new technology that can render medical linens and clothing, face masks, paper towels, and other objects permanently germ-free. Because the antimicrobial agent is nonleaching, it is suitable for medical devices such as IV bags and tubing....
  • An Evolving Debate: Form Vs. Function in Medical Device Design

    Function has often taken precedence over form in medical device design. But as healthcare increasingly moves from the hospital to the home and into the hands of the consumer or patient population, the debate over form versus function in medical device design appears to be reaching a fever pitch.While the importance of function in medical device design is indisputable, incorporating a user-friendly design is quickly becoming just as critical to a medical device's success. Cambridge Consultants,...
  • Medtech Week in Review

    From Medtronics's acquisitions of Salient and Peak to Boston Scientific's plea to Congress to repeal the medical device tax, the past week has been a busy and active one on the medical device front. But aside from media-grabbing headlines involving the industry's heavy hitters, the medtech sphere has also been replete with news about new microfluidic technologies, novel antimicrobial concepts, and the importance of everyday patients as seekers of medical information. Check out the following...
  • Energy-scavenging Printed Device Captures Ambient Electromagnetic Energy

    Energy transmitted from sources such as radio and television transmitters and cell phone networks have often been considered troublesome when it comes to medical device and electromagnetic interference, but a new technique developed by researchers at Georgia Institute of Technology (Atlanta, GA) can capture this ambient energy and use it to power small electronic devices. This emerging wireless technology could be used for medical applications including wearable bio-monitoring devices for...
  • Copper: Newest Antimicrobial Metal on the Block

    Copper is increasingly catching the attention of researchers dedicated to the development of antimicrobial materials. Among them is Bill Keevil, head of the microbiology group and director of the environmental healthcare unit at the University of Southampton (UK), who has analyzed how copper exerts its antimicrobial effect on antibiotic-resistant organisms. The survival of pathogens on conventional hospital touch surfaces, according to Keevil, contributes to the increasing incidence and spread...