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RTC MAGAZINE

Given Imaging Submits PillCam® COLON 2 Application to FDA For U.S. Regulatory Clearance

YOQNEAM,Israel – November 27,2012 – Given ImagingLtd{NASDAQ:GIVN),a world leader in Gl medical devices and pioneer of capsule endoscopy, today announced that it has filed a U.S. Food and Drug Administration {FDA) application seeking regulatory clearance to market its PillCam® COLON 2 for visualization of the lower gastrointestinal tract. “Filing for FDA clearance is another important...

RTC Group Taps Industry Leader Clarence Peckham, Brings His Technology/Market Expertise to Publications Team as Senior Editor

SAN CLEMENTE, CALIF., NOVEMBER 28, 2012 – RTC Group, Inc.,—foremost supplier of marketing resources to the embedded computing industry and publisher of premier industry technology publications including RTC, MEDS and COTS Journal —announces industry leader Clarence Peckham has joined the RTC Group’s editorial team. With more than 30 years of engineering and senior management expertise...

Embedded Technologies Help Make High-Speed DNA Testing More Intuitive

Embedded Technologies Help Make High-Speed DNA Testing More Intuitive DNA analysis has gone from mere theory to a heavily relied upon analytic and diagnostic tool in just a few short decades. But as invaluable as DNA can be, its longtime drawbacks have been the time required to replicate enough of it from very small samples...

Ten Truths about Building Safe Software for Medical Devices

Obtaining pre-market approval for a medical device is arduous. Manufacturers must look beyond the strictly technical challenges and focus on the needed environment and culture. They must consider ten fundamental truths—truths that we must tell and truths that we must face—about building and gaining approval for medical devices. by Yi Zheng and Chris Hobbs, QNX...

UL Acquires Wiklund Research & Design, Adds Human Factors Engineering Expertise to Life & Health Offerings

    Leading human factors engineering business enables UL to fully support medical and diagnostic device manufacturers throughout the product lifecycle NORTHBROOK, Ill. / Concord, Mass. – November 9, 2012 – UL, a world leader in advancing safety, announced today the acquisition of Wiklund Research & Design, Inc. Wiklund Research & Design provides user research,...

Interview of OCTANe

OCTANe is a large medical device consortium based in Orange County, CA . They hold more than 50 events a year to bring together people, capital, ideas and technology in southern California.  Their signature event, the Medical Device Investor Forum (MDIF, http://www.mdif2012.com/main.html), connects investors and many medtech companies together to form partnerships, raise funds, develop...

TI introduces the industry’s first weigh scale and body composition analog front end

      DALLAS (August 1, 2012) – Texas Instruments Incorporated (TI) (NASDAQ: TXN) today unveiled the industry’s first fully integrated analog front end for both weight and body composition measurement (BCM).  The AFE4300 is an easy-to-use, precision, low-power front end solution, which allows engineers designing weigh scales that incorporate body composition meters, body impedance...

Philips and RAD-AID demonstrate commitment to women’s healthcare at 2012 Clinton Global Initiative Annual Meeting

September 24, 2012 Philips and RAD-AID demonstrate commitment to women’s healthcare at 2012 Clinton Global Initiative Annual Meeting  New York, N.Y., U.S. – Royal Philips Electronics (NYSE: PHG, AEX: PHI) announced today that the Clinton Global Initiative (CGI) is featuring Asha Jyoti, a collaborative women’s healthcare outreach program established by RAD-AID International, Philips Healthcare, and...

UL 2560 and Emergency Call Systems: Expanding the standards framework

UL Emergency Call System – Click to view PDF

MEDICAL DEVICE MANUFACTURERS ADDRESS COMPLIANCE MANDATES WITH PRODUCT LIFECYCLE MANAGEMENT

MEDICAL DEVICE MANUFACTURERS ADDRESS COMPLIANCE MANDATES WITH PRODUCT LIFECYCLE MANAGEMENT By Eric Marks Based on industry statistics, it is obvious that intensified regulatory scrutiny has become a harsh reality for medical device manufacturers. Over the last several years, medical device companies have been hit with injunctions, undergone product recalls, or found themselves operating under the...

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