Misonix CEO steps down Misonix (NSDQ:MSON) CEO Michael McManus, Jr. stepped down in early September, also leaving his post as director and chairman of the board of directors. Stavros Vizirgianakis, a member of the board of directors, is serving as the interim CEO while negotiating for a full-time position in the corner office. Vizirgiankis, who owned […]
Medtronic
Medtronic touts 1-year data on Avalus surgical aortic valve
Medtronic (NYSE:MDT) today reported 1-year results from a clinical trial of its Avalus pericardial aortic surgical valve, touting low rates of adverse valve-related events and high survival numbers. Data from the study were presented at the European Assn. for Cardio-Thoracic Surgery’s annual meeting in Barcelona this week. “With more than 25 years of experience in the surgical valve space, […]
Medtronic’s HeartWare faces 2 Class I FDA recalls
Medtronic (NYSE:MDT) said today the FDA labeled 2 outstanding global voluntary recalls related to subsidiary HeartWare International‘s HVAD system as Class 1. A Class 1 indication from the federal watchdog indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency. The voluntary recall is related […]
Medtronic issues urgent field safety notice for select ICDs, CRTds
Medtronic (NYSE:MDT) issued an urgent field safety notice concerning issues with specific units of its Viva cardiac resynchronization therapy defibrillators and Evera implantable cardioverter defibrillators that could result in rapid battery depletion. The Fridley, Minn.-based company sent the notice on August 12 to healthcare professionals managing patients with the devices. The notice warned of issues […]
FDA approves Medtronic’s ‘artificial pancreas’ MinMed 670G hybrid closed loop system
The FDA today granted premarket approval to Medtronic (NYSE:MDT) for its MiniMed 670G ‘artificial pancreas’ hybrid closed loop system, making it the 1st system of its kind to win clearance globally. The MiniMed 670G is designed to automatically track and adjust blood sugar levels in patients with diabetes, measuring blood glucose every 5 minutes and automatically administering […]
Medtronic wins FDA nods for TrailBlazer peripheral support cath
Medtronic (NYSE:MDT) said today it won FDA 510(k) clearance for its TrailBlazer angled support catheter designed for use in the peripheral vascular system. The Fridley, Minn.-based company’s newly cleared TrailBlazer cath is designed to support a guide wire during peripheral artery access to enable the delivery of solutions and diagnostic agents. Support catheters, such as […]
Medtronic touts 1st-in-human use of Sugar.IQ with Watson ‘cognitive app’
Medtronic (NYSE:MDT) said today it launched its Sugar.IQ with Watson ‘cognitive app’ for people living with diabetes. The 1st users participating in the testing of the final release candidate will provide information about the app’s usability and function, the Fridley, Minn.-based company said. The Sugar.IQ app was developed to integrate Medtronic’s continuous glucose monitoring sensors with IBM (NYSE:IBM) Watson […]
FDA clears Medtronic’s StealthStation DBS lead placement software
Medtronic (NYSE:MDT) said today that the FDA granted 510(k) clearance for its StealthStation software, which is designed to help plan the placement of the leads used for deep-brain stimulation therapy. Fridley, Minn.-based Medtronic said StealthStation is designed to work with its O-arm imaging system to integrate pre-operative planning and intraoperative imaging during DBS device implantations. “The […]
Medtronic opens diabetes HQ in Minnesota
Medtronic (NYSE:MDT) said this month that it opened a new headquarters for its non-intensive diabetes therapy business in Plymouth, Minn. The newly opened facility will act as the global headquarters for the company’s NDT biz, as well as housing product development, research & development, marketing and operations, Fridley, Minn.-based Medtronic said. “Having our own space means […]
Medtronic escapes Infuse lawsuits involving fugitive Ohio doc
UPDATED Oct. 3, 2016, with news of Durrani’s whereabouts. Medtronic (NYSE:MDT) yesterday escaped hundreds of lawsuits filed over the allegedly off-label use of its controversial bone-growth product, Infuse, by a Cincinnati doctor who has since fled to Pakistan. Infuse consists of a collagen sponge that’s soaked in a bone-growth protein called recombinant human bone morphogenetic protein-2 […]
Medtronic touts low CD-TLR rates, strong durability in 3-year In.Pact Admiral DCB study | VIVA 2016 Roundup
Medtronic (NYSE:MDT) this week released data from 2 clinical studies evaluating its In.Pact Admiral drug-coated balloon for treating claudication and restenosis, touting sustained durability at 3-years. Results were presented at the Vascular Interventional Advances 2016 conference in Las Vegas this week. Those of you who want strength without size, lean muscles, or if you’re cutting, http://topsteroidsforsale.com is relatively safe […]