Boston Scientific (BSX) announced the medical device company has received a CE Mark for its Lotus Valve System, which offers alternative treatment for high-risk patients with sever aortic stenosis. The advanced transcatheter aortic valve replacement (TAVR) technology, the company claims, is “the only aortic valve device that can be assessed in its final position prior […]
The healthcare startups in the race to launch an approved noninvasive, bloodless glucose meter for the growing diabetes patient population is on. While each company etches out its value proposition and aims for commercial launch, a look at what the devices with potential for success in this space have in common. What the successful breakout […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
St. Jude Medical (STJ) announced it has acquired Nanostim, Inc., a California-based early-stage medical device company focused on leadless pacemaker technology, for $123.5 million. The startup could stand to gain up to an additional $65 million if it meets certain milestones. This deal culminates a partnership that began on May 3, 2011, when STJ decided […]
The standard of care for port site closures in laparoscopic surgery may be changing. Irish medical device startup neoSurgical‘s first commercialized product, neoClose, officially launched this week in the U.S. Today, the Society of Laparoendoscopic Surgeons named the device one of the 2013 Innovations of the Year at the SLS Minimally Invasive Surgery Week Annual Meeting. […]
What with the medical device tax and regulatory hurdles, there is a lot of medical device startups are contemplating beginning business in Europe. But before you leap, look. Is America or Europe right for your company? Here are four tips to mull over from two CEOs who lead startups that have a strong European presence. […]
Think shock absorbers for the human body. Moximed could help active and young patients who have osteoarthritis prolong the amount of time before total knee replacement. The Heyward, Calif.-based company’s Kinespring Knee Implant System is a medical device that absorbs part of the load put on the knee, without changing anatomy. The device is positioned […]
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Edwards LifeSciences Corp. reported a total revenue of $517 million for Q2, with 7.3 percent increased net sales, “driven by strong sales of transcatheter and surgical heart valves in both the U.S. and Europe,” CEO Michael Mussalem said. Combined, the two provided 16 percent of sales in the U.S., helped by the SAPIEN launch in the U.S.. […]
With the ever-increasing stringency, time, and expense associated with FDA approval for medical devices, debate is sharpening in the medical devices industry over whether it is actually better business strategy to prioritize getting a CE mark for your product. This article gives an overview of a recent iteration of a robust debate within the Medical […]