Regulatory

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.

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.

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

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.

The FDA has issued a Class I recall for the Cook Medical, Inc., Zilver PTX Drug-Eluting Peripheral Stent. All sizes, diameters and lot numbers manufactured prior to April 16 2013 are implicated.

Sequent Medical, Inc. has gained the CE mark for the SL (“Single Layer”) family of WEB® Aneurysm Embolization Devices, and … continue reading “CE Mark And EU Launch For Sequent Medical’s New SL Family of Web Aneurysm Embolization Devices”

Medical Device Firm iTraumaCareTM Receives FDA 510(k) Clearance for iTClampTM Hemorrhage Control System

Boston Scientific Corporation has gained CE Mark approval for use of the GUIDE™ DBS System, the world’s first deep brain … continue reading “CE Mark For Boston Scientific’s GUIDE™ DBS System”

Hill-Rom Holdings, Inc. has received 510(k) clearance from the U.S. FDA to market the MetaNeb® 4.0 airway clearance system. The system helps enhance normal mucus clearance from the lungs, delivers lung expansion therapy, and assists in the treatment and prevention of pulmonary atelectasis, a complete or partial collapse of the lung.

Medtronic, Inc. has received CE Mark approval for valve-in-valve (VIV) procedures using the CoreValve® and CoreValve® Evolut™ transcatheter aortic valve implantation (TAVI) systems in degenerated bioprosthetic surgical aortic valves.

The newly CE marked XIENCE Xpedition™ 48 coronary stent leverages the well established design and clinical outcomes of the XIENCE Family of Drug Eluting Stents. A longer stent, compared with multiple short stents has the potential to reduce overall procedural costs, particularly in very long lesions most often seen in patients with diabetes.

The FDA has issued a Class I recall, it’s highest category, for Abbott Diabetes Care, FreeStyle InsuLinx Blood Glucose Meters. … continue reading “FDA Class 1 Recall For Abbott Diabetes Care’s FreeStyle InsuLinx Blood Glucose Meters”