Products

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”

OrbusNeich has launched what it is hoping will be a new genre of coronary stent. The company’s COMBO Dual Therapy … continue reading “Cardiologists Can Have Cake And Eat It With OrbusNeich’s Dual Therapy Stent”

K2M, Inc., a company famously focused on the more complex spine pathologies, has launched its MESA® Small Stature Spinal System … continue reading “K2M Introduces Its Small Stature Posterior Spinal Fixation System In EU And Antipodes”

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”

Covidien’s Nellcor™ pulse oximetry systems have received U.S. FDA 510(k) clearance for so-called “motion” claims. This makes Covidien the first company to receive FDA clearance for a motion-tolerant bedside pulse oximeter portfolio.

Thoratec Corporation has received approval from the U.S. FDA to market the HeartMate II® Pocket Controller™, a device it calls the small, smart, safe face of the HeartMate II LVAD System.

Devon Medical, Inc. has received the CE mark for its portable extriCARE® 2400 Negative Pressure Wound Therapy (NPWT) system. NPWT has … continue reading “CE Mark For Devon Medical’s extriCARE® Portable Negative Pressure Wound Therapy System”

Tryton Medical, Inc., specialist in stents designed to treat bifurcation lesions, has gained CE Mark approval for its Tryton Side … continue reading “CE Mark For Next-Generation Tryton Side Branch SHORT Stent”

Biosensors International says its newly CE Marked BioMatrix NeoFlex™ drug-eluting stent builds on the strengths of its predecessor, but with enhanced pusability, trackability and crossability..

Direct Flow Medical Inc. has received FDA approval for an Investigational Device Exemption (IDE) to begin the SALUS feasibility trial of its novel transcatheter aortic valve system. We’ll be watching to see whether this study replicates EU study results showing a reduction in valve regurgitation.