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Siemens Recalls MicroScan Synergies plus® and rapID/S plus Gram Negative Panels

•  Siemens  recalls specific panels shipped June 2011 through August 2013 Siemens Healthcare Diagnostics has issued a voluntary recall of its MicroScan Synergies plus® Negative and rapID/S plus Negative panels. These panels are used for determining antimicrobial susceptibility and/or identification for gram-negative bacteria. An internal investigation has confirmed an increase in false susceptible and false...

SIEMENS UNVEILS VERSACELL X3 SOLUTION AT AACC 2013

Press Healthcare Sector Diagnostics Division Houston, Texas, July 31, 2013 Siemens Unveils VersaCell X3 Solution at AACC 2013 Siemens Healthcare Diagnostics further expanded its industry-leading clinical laboratory automation portfolio¹ by unveiling VersaCell® X3 Solution² at the 2013 AACC and ASCLS Annual Meeting and Clinical Lab Expo in Houston, July 28 – August 1 (Booth #3449)....

Given Imaging Receives FDA Clearance for Next Generation PillCam® SB 3

– Improved PillCam SB technology provides a more detailed and efficient small bowel examination for patients with conditions such as Crohn’s disease and obscure GI bleeding – YOQNEAM, ISRAEL, August 13, 2013– Given Imaging Ltd, (NASDAQ: GIVN), a world leader in GI medical devices and the pioneer of capsule endoscopy, today announced that the United...

Cambashi research maps key providers to industry

The latest Cambashi observatory shows which technical applications providers serve key industries Cambridge, UK, Aug 15, 2013- Cambashi today announced the latest addition to their market data resource as the Cambashi Provider by Industry Observatory. This offers a view of the industries where the key technical applications software providers are most active, enabling new and...

MobileLink Receives FDA 510(k) Clearance

WALTHAM, Mass., Aug. 5, 2013- Alere™ Connect (an Alere Company) has been granted a 510(k) market clearance by the U.S. Food and Drug Administration for theAlere™ MobileLink. The new product offering is one of Alere’s connected device technologies designed to empower patients by allowing self-testing at home and delivering data quickly and seamlessly to clinical systems...

The Ultrasound Revolution – A Spotlight on Imaging Technology

Among all the medical devices used by doctors, ultrasound has had a unique quality attached to it. It possesses a power that distinguishes it from other devices—the power to “see by sound.” It’s an interesting concept that has ultimately changed medical imaging today and will most likely power the future of imaging. In 1952 ultrasound...

Medical Device Manufacturers Address Compliance Mandates with Product Lifecycle Management

A paper trail is no longer acceptable. Meeting the stringent requirements for FDA compliance as well as meeting challenging time to market deadlines requires automation. Product life cycle management systems can make a big difference for both goals. Based on industry statistics, it is obvious that intensified regulatory scrutiny has become a harsh reality for...

AAMI 2013 Conference Report

AAMI, the Association for the Advancement of Medical Instrumentation, is a nonprofit organization founded in 1967. It recently held a conference in Long Beach, CA. It brought together healthcare professionals and engineers from around the world to learn, share and network under one roof. I had a chance to attend the conference and I spoke...

Philips CX50 xMATRIX now offers world-class interventional and diagnostic features on single portable system

      Available Live 3D TEE and new breakthrough ICE catheter to reduce need for two separate cardiac ultrasound systems Andover, Mass., U.S.A. – Royal Philips Electronics (NYSE: PHG, AEX: PHIA) today announced that CX50 xMATRIX, the world’s first portable ultrasound with Philips’ industry leading Live 3D TEE, now offers 2-D Intracardiac Echo (ICE)...

Amendment 1 to IEC 60601-1:2005

Charles B. Sidebottom, P.E., Director, Corporate Standards, Medtronic Inc.; Secretary, IEC SC 62A; Secretary, ISO TC 150, SC 5 13 May 2013 For more than 35 years, IEC 60601-1 has been one of the most widely recognized standards for demonstrating the safety of medical electrical equipment. The IEC 60601 family of standards has long been...

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