Products

Tissue processing and device company CryoLife, Inc.,has gained a CE Mark for its new iteration HeRO (Hemodialysis Reliable Outflow) Graft … continue reading “CE Mark For CryoLife’s New HeRo® Graft”

Orthopaedic product sales exceeded $43 billion in 2012, a modest increase of 3% or $1.2 billion over 2011, according to market intelligence specialist ORTHOWORLD®. Segments contributing greatest growth included trauma at $6.1 billion and sports medicine at $4.2 billion. Spine posted negative growth, while hips, knees, extremities and orthobiologics posted growth in the low-single digits.

Cardiac arrhythmia specialist company, Cardiac Insight, Inc., has received US FDA 510(k) clearance for its Stealth™ body-worn ECG monitor

The medical device industry brings life-saving and health-giving technology to the world. The funny thing is that from a global … continue reading “This week’s “View From The Med” blog online now”

GE Healthcare has gained FDA 510(k) clearance for its latest Brivo Plus C-arm, which is now available in the US. The pitch for the newly cleared device is that with legacy OEC image quality and ease-of-use, the affordability and reliability of this new Brivo C-arm will offer a high quality, economically attractive option for basic surgical imaging.

Cook Medical has received  FDA 510(k) clearance for its Evolution® Biliary Controlled-Release Uncovered Stent. The company says its device is the … continue reading “FDA Clears Cook’s Evolution® Biliary Controlled-Release Uncovered Stent”

Metal-on-metal hip problems are associated with J&J’s DePuy division with its infamous and ongoing ASR tribulations. Stryker isn’t without its … continue reading “Stryker ABG II Lawsuit Claim For $100M”

Peripheral Vascular Disease therapies include the use of percutaneous transluminal angioplasty(PTA) using a balloon catheter. While recent news has been all about the race to (U.S.) market for drug eluting varieties, Medtronic is no doubt hoping its Pacific Plus device is sufficiently feature-packed to take a chunk of the market until their drug eluter gains approval.

According to a release from the UK’s MHRA, its Swedish equivalent has adopted the position that PI implants should be removed as a precautionary measure. The MHRA has issued its own statement reasserting its position that this is not necessary in all cases.

ArtVentive Medical Group, Inc. has received European CE Mark certification for the ArtVentive EOS™ Peripheral Vascular Endoluminal Occlusion system. The company is very coy about sharing its IP, to the extent that we’re not really sure how it works. But studies suggest it’s 100% effective, which is good enough for the CE brigade.

Market intelligence company Millennium Research Group (MRG), reckons the 2013 Japanese launch of transcatheter aortic valve implants, will spur accelerating growth in the market. Earthquakes, the tsunami and economic factors might hold things back a bit though.

The FDA has granted 510(k) clearance to a muscle and joint rehabilitation medical device that tricks the brain into re-establishing communication with muscles affected by brain or spinal cord damage.

Seemingly hardly off our pages in recent weeks, Biosensors International Group, Ltd., cardio device company has entered into a licensing … continue reading “Biosensors Steps Into Drug Eluting Balloon Markets With Eurocor OEM Deal”

Medtronic, Inc. is showcasing its newly approved stent graft at this weekend’s Vascular Annual Meeting, taking place in San Francisco. The company has gained FDA approval for the Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System and the FDA 510(k) clearance for the Sentrant Introducer Sheath

joimax® will introduce its novel EndoLIF® system for endoscopic stabilization of the lumbar spine to the broad expert audience of DGNC’s Annual Meeting in Düsseldorf, Germany, this week.

The UK’s regulatory agency, the MHRA has issued a device alert relating to reinforced endotracheal (ET) tubes manufactured by Convatec company Unomedical The device types are Murphy, Magill, Murphy with stylet and Magill with stylet.