UPDATE: Updated to include comments from Ascensia Medtronic (NYSE:MDT) and Dexcom (NSDQ:DXCM) today announced respective wins for their diabetes care tech, with Medtronic launching its hybrid closed loop MiniMed 670G in the US and Dexcom winning an FDA nod for a Google (NSDQ:GOOG) Android G5 Mobile application. Fridley, Minn.-based Medtronic’s MiniMed 670G is designed to automatically track and adjust […]
Medtronic
India regulator wants price caps on more coronary, peripheral devices
Indian healthcare regulators reportedly reversed course and are now asking for a quartet of medical devices to be added to a list of products under price control. India’s National Pharmaceutical Pricing Authority wants its list of price-capped products updated to include balloon and cardiac catheters, covered stents and peripheral stents, Reuters reported. If the government there approves, they […]
Why U.S. first may be the new medical device development strategy
Increased regulatory hurdles in Europe and China could mean more medical device development focusing on the U.S. market first. That seemed to be a major takeaway from panels on regulation and reimbursement at Healthegy’s Medtech Conference, held last week in Minneapolis. “We’re actually going to be doing more early clinical work with the FDA,” said Stacey Pugh, vice […]
Medtronic wins Health Canada nod for SureTune3 DBS software
Medtronic (NYSE:MDT) said today it won Health Canada approval for its SureTune3 software designed for programming deep brain stimulation therapy. The Fridley, Minn.-based company said the DBS Therapy system is licensed by Health Canada for treating diseases such as Parkinsons and for treating symptoms such as tremors through the application of mild electrical stimulation to precise targets in […]
DJO Global names new surgical prez | Personnel Moves – June 1, 2017
DJO Global said this week that it hired Jeffery McCaully as global president of its surgical business, effectively immediately. McCaulley succeeded Brady Shirley, who was named DJO’s president & CEO in November last year. McCaulley previously served as president & CEO of Smiths Medical, as well as president of Zimmer Biomet‘s (NYSE:ZBH) global reconstructive unit, where […]
UPDATE: Medtronic recalls Kyphon bone cement device
Medtronic (NYSE:MDT) is recalling some of its Kyphon instruments that deliver bone cement after discovering a misalignment issue with the devices.* The Fridley, Minn.-based company sent a letter to customers last month detailing the issue with the Kyphon directional bone filler, saying it received 2 reports that “the directional arrow at the proximal end of […]
Medtronic launches opioid-induced respiratory depression study
Medtronic (NYSE:MDT) said today that it’s starting a large study on the effect of pulse oximetry and capnography in opioid-induced respiratory depression, using its Capnostream device. The 1,650-patient Prodigy study aims to create a tool to score the risk of OIRD in patients being treated with opioids for pain, using Capnostream’s continuous pulse oximetry and capnography monitoring […]
Medtronic increases stake in Saluda Medical
Saluda Medical said it raised nearly $40 million (A$53 million) for the Evoke closed-loop neuromodulation device it’s developing to treat axial back pain. The round was led by a new investor, GlaxoSmithKline‘s (NYSE:GSK) Action Potential Venture Capital, joined by existing backer Medtronic (NYSE:MDT), Artarmon, Australia- and Bloomington, Minn.-based Saluda said. The Evoke spinal cord stimulator is […]
Artificial pancreas: These companies are racing to make one
Medical device companies are close to achieving the holy grail of diabetes treatment: a combined glucose sensor, control algorithm and insulin infusion device that effectively acts as an “artificial pancreas.” We explain more in the newest video from editors at MassDevice’s sister publication Medical Design & Outsourcing. (And for a deeper dive, check out our recent […]
Medtronic beats The Street with fiscal Q4, 2017 results
Medtronic (NYSE:MDT) posted sales and earnings that topped Wall Street’s estimates for its fiscal 4th quarter and 2017, as its full-year bottom line grew nearly 14% on sales growth of 3%. The world’s largest medical device company reported profits of $1.16 billion, or 84¢ per share, on sales of $7.92 billion for the 3 months […]
Medtronic launches study of In.Pact Admiral drug-coated balloon in end-stage renal disease
Medtronic (NYSE:MDT) said today that the 1st patient was enrolled in a study of its In.Pact Admiral drug-coated balloon in patients with end-stage renal disease. The FDA approved the investigational device exemption study to evaluate the device as a treatment for failing arteriovenous fistulas in end-stage renal disease patients. Get the full story at our sister […]