Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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Dexcom shares have slipped nearly 6% since the continuous glucose monitoring company released its 1st-quarter results April 27 after the company missed Wall Street’s earnings expectation.
San Diego-based Dexcom reported that losses widened 48.8% to -$19.2 million, or -23¢ per share, on sales of $116.2 million for the 3 months ended March 31 – for a top-line gain amounting to a whopping 59.6%. Still, losses were a penny behind The Street’s consensus for losses of -22¢. Read more
Halyard Health is battling a 60 Minutes story from CBS accusing Halyard of providing defective Microcool surgical gowns, meant to protect workers from blood transmitted diseases, to health care workers during the Ebola outbreak of 2014.
The show reported that the gowns, which are recommended by the Centers for Disease Control and have AAMI Level 4 standards of impermeability to prevent transmission, had faulty seams and regularly leaked. Read more
Medtronic today said it won FDA clearance for its StrataMR valves and shunts for patients with hydrocephalus and cerebrospinal fluid conditions.
The clearance allows the valves and shunts to be used during MRI scans at their performance level setting at up to 3.0 Tesla, Fridley, Minn.-based Medtronic said. StrataMR is slated to be available “in the coming months,” the company said. Read more
EnteroMedics said today that it signed a distribution deal for its Maestro weight-loss device with Academy Medical, an orthopedic implant and wound care supplier to the U.S. Veterans Affairs Dept. and the U.S. Defense Dept.
The Maestro device is an implantable neurostimulation device designed to intermittently block the vagus nerves using high-frequency, low-energy impulses. The therapy, which St. Paul, Minn.-based EnteroMedics calls “vBloc,” is approved in the U.S., Europe and Australia to aid in weight loss in obese adults with a body mass index of 40 to 45 or a related health condition and a BMI of 35 to 39.9. Read more
Medtronic said it won FDA approval for its Visia AF line of implantable cardioverter defibrillators, which are designed to detect and monitor atrial fibrillation symptoms.
Fridley, Minn.-based Medtronic said it plans to have the Visia AF MRI SureScan and Visia AF single-chamber ICDs on the market in early summer. The devices won CE Mark approval in the European Union last October. Read more