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…
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)….
– 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…
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…
July, 2013
- By: by Eric Marks, Price Waterhouse Cooper, by Eric Marks, Price Waterhouse Cooper
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, 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…
June, 2013
- By: By Charles Sidebottom
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 recognized by regulatory agencies in Europe, North and South America, and Asia as establishing conformance with their regulatory requirements….
June, 2013
- By: By Florian Herrmann and Karsten Aalders, Stollmann
Part 1 The Health Device Profile along with the IEEE 11073 protocol is enabling a number of specific medical devices to communicate data via multiple logical channels carried by a single master radio channel for compatible device communication. Profiles play a central role in the Bluetooth Specification. They define the entire protocol stack, usually including…
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)…
May, 2013
- By: John Koon, Publisher, MEDS Magazine
The medical technology ecosystem is an ever expanding and complex food chain. Most noticeable are the manufacturers building medical devices of FDA class I, II and III such as EKG machines, blood pressure monitors, blood glucose monitors, insulin pumps, ultrasound systems, implantable defibrillators, wearable devices and all sorts of wireless monitors. The list goes on…
May, 2013
- By: by David Hirning MS and Virginia A Lang, PhD, HirnLan, Inc.
Get ahead of stringent design cycles by evaluating the human factors and usability of a device early in the process. When the demands for meeting these requirements come from the FDA, as they almost certainly will, your product and your team will be ready. by David Hirning MS and Virginia A Lang, PhD, HirnLan, Inc….
Insulet to Develop New Version of the OmniPod Insulin Pump for Use with Humulin R U-500 Concentrated Insulin for People with Type 2 Diabetes BEDFORD, MA, May 2, 2013 – Insulet Corporation (NASDAQ: PODD), the leader in tubeless insulin pump technology with its OmniPod® Insulin Management System, today announced it has entered into an agreement…
