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February 15, 2011

The future of innovation may rest in the hands of FDA

By Sherrie Conroy, Director of Content

Innovation and competition. These go hand in hand and they are the topic of nearly every press conference and land on the agenda of almost every industry meeting. But the focus is not how to innovate. Rather, it’s on why the US leadership position is in jeopardy—and what we need to do to stop further erosion. And while fixing the problem is more important than fixing blame, all eyes are on FDA. Studies, reports, and experts all say that FDA, while not the whole problem, plays a crucial role in reversing this trend. We don’t mean to pressure you FDA, but our future is sitting squarely on your shoulders. “We’re facing critical issues. Our watchword for the year is competitiveness,” said James Mazzo, president of Abbott Medical Optics and chairman of AdvaMed. “The press is talking about it; members of Congress are talking about it. It’s going to be the driving force for AdvaMed’s advocacy agenda for the foreseeable future.” Mazzo and AdvaMed president Steve Ubl spoke in detail on this topic at a press conference in February. And there are reasons for concern. Mazzo said that he is concerned that our innovation could be slipping because of the regulatory issues. “The recent PwC report echoed those concerns. America’s positive trade balance for medical technology continues to shrink. Venture capital investment is growing faster in Europe than it is in America.” And how does VC funding fit into this regulatory picture? VCs, he said, are reluctant to fund our early-stage companies, meaning that “some potentially game-changing technologies will never see the light of day here in the United States.” Read More

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RFID found effective in preventing retained surgical items

Radio-frequency identification (RFID) technology has been found to be 100% effective in terms of sensitivity and specificity in patients of varying body size. This assertion is detailed in the first published data from RF Surgical Systems, Inc, Bellevue, WA, on the potential uses of RFID in applications for identifying retained surgical items (RSI). The study, which included morbidly obese patients, addresses the concern that, “surgical count discrepancies can occur as often as one out of eight surgical cases, and sponges are more difficult to find in morbidly obese patients,” according to Victoria M. Steelman, lead author of the study.

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Bimba Introduces New Electric Actuators
After more than 50 years of pneumatic leadership, Bimba introduces its first ever rod-type electric actuator—the Original Line Electric (OLE). Designed, built and tested to provide the greatest durability, highest speed and most thrust per dollar, Bimba’s OLE actuators are ideal for applications requiring increased control and flexibility. Just like Bimba’s trusted Original Line pneumatic cylinders, OLE actuators deliver the quality, durability, delivery and outstanding customer service you’ve come to expect.

Wireless EEG enables remote neuro-feedback monitoring

Wireless electroencephalogram systems (EEG) technologies that can enable continuous ambulatory monitoring were presented at MD&M West in Anaheim, CA. Imec, Leuven, Belgium, a nanoelectronics research company, and R&D provider Holst Centre, Eindhoven, The Netherlands, demonstrated a prototype headset that records high-quality EEG signals and wirelessly transmits real-time data to a receiver located 10 m from the system. Compatible with dry electrodes, the prototype headset features ultra-low-power electronics and is designed with ease-of-use in mind. Medical applications suggested for the wireless EEG technologies include an early warning system for epileptic patients and brain-typing systems that could enable people with motor disabilities to communicate.

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Nobel Biocare develops biocompatible dental caps

Designed for dental implant applications, dental healing caps are molded out of polysulfone (PSU) resin that features toughness, biocompatibility, and sterilizability. The dental healing caps are the result of a collaboration between Nobel Biocare, Zurich, a supplier of restorative and aesthetic dental products, and plastics producer Solvay Advanced Polymers, Alpharetta, GA. Solvay supplied the Eviva PSU resin used to make the caps. The resin is part of Solvay’s Solviva line of biomaterials designed for use in implantable medical devices.

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New Products

Analog front-end subsystem for diagnostic-quality ECG applications

The first product in a series of fully integrated analog front-end (AFE) chips enables ECG systems to achieve monitor- and diagnostic-quality performance. The device also incorporates pacemaker pulse detection and respiration measurement. Analog Devices, Inc ADAS1000 ECG AFE simplifies the design of a five-electrode ECG system by significantly reducing the signal chain bill of materials from up to 50 components down to the ADAS1000 single chip plus a few discrete components. The device can be configured to optimize noise performance, power, or data rate—making it suitable for home, ambulatory, and clinical ECG systems.

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Cable compound for medical and electrical applications

A compound based on decades of development for high-performance electrical applications has been formulated to also meet stringent medical requirements for reliability, as well as cytotoxicity and chemical resistance. Part of the Medalist family of medical elastomers from the thermoplastic elastomer (TPE) division of Teknor Apex Co, Pawtucket, RI, the high-purity Medalist MD458 compound for wire and cable features protective insulation and jacketing. It is designed to provide the same electrical performance and elevated service temperature rating as the supplier’s established Elexar EL8431 TPE in a medical-grade form.

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Shielded connector for medical interconnects

Constructed to protect medical interconnects from EMI and RFI, a shielded connector is designed to prevent signal interruptions in medical equipment with high data transfer rates. Hypertronics Corp, Hudson, MA, has created the Shielded HyperGrip connector for use with such sensitive equipment as homecare cardiac devices, patient monitoring, and imaging and electrophysiology catheter systems. Providing continuous shielding from interference with an attenuation of -50db at 3 GHz, the connector can help maintain optimum performance levels and service life.

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