The Medical Device Business Journal — Medical Device News & Articles | MassDevice
The FDA approved a new Medtronic (NYSE:MDT) stent for peripheral arterial disease and green-lighted a pivotal clinical trial of a so-called “artificial pancreas” for Type I diabetics.
The pair of regulatory wins follow a decision that didn’t go Medtronic’s way, after an FDA panel last week recommended against approval of one of its cardiac ablation devices for a type of atrial fibrillation.
Hospital group purchasing organizations Novation and Premier signed seven new contracts this week for everything from surgical safety technology to central venous access catheters.
Novation awarded a three-year contract to Teleflex Inc. (NYSE:TFX) for its respiratory, anesthesia airway, central venous access, endotracheal tubes and chest drainage products.
Baxter International Inc. (NYSE: BAX) won an expanded indication for its Artiss fibrin sealant, making it available for use during in sealing tissue flaps during face-lift surgeries.
Artiss first won FDA clearance in 2008 for use in adhering skin grafts in wound beds prepared for treating burns in adults and children over the age of one.
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Hemosphere Inc., which sells a vein-access device for chronic kidney disease patients, has hired a former St. Jude Medical (NYSE:STJ) sales and marketing leader as its new chief executive.
Patrick Wethington spent about 10 years with St. Jude before his most recent post, vice president of sales and marketing at Sweden-based Gambro Inc., which also sells medical technology aimed at patients with kidney problems.
After more than 20 years in corporate America, Doris Engibous says she was “big-companied out.”
So the medical technology veteran jumped at the opportunity to move from California to Minnesota six years ago to become a first-time CEO for Hemosphere Inc., which has developed a vein-access device for chronic kidney disease patients who need hemodialysis.
Hemosphere Inc, which makes a vascular access device that’s used by dialysis patients, raised more than $9.3 million in an equity sale, according to a regulatory filing.
