Corporate tax inversions, including Medtronic's planned shift to Ireland following its purchase of Covidien, are causing a backlash among some shareholders stuck with a big tax bill becaues of capital gains taxes associated with the deal.
AliveCor announced Aug. 21 that it has received FDA clearance for an algorithm to detect atrial fibrillation, and next month it plans to incorporate the new ability into its AliveECG app for monitoring the heart.
Claret Medical roped in $18 million in Series B financing to support development of its cerebral protection system for transcatheter aortic valve replacement.
Even if they don't work well or are a bit unsightly, consumer wearable health devices are undeniably trendy. A new startup is taking a more practical approach to tapping into the wearables market--creating business applications for wearable technologies like Google Glass.
Invacare has struggled to right itself for years, but thus far has failed to recover from an ongoing FDA investigation of a wheelchair manufacturing facility that first started in December 2011. Now it has undertaken its latest restructuring in an effort to return to profitability. The home and long-term medical products company started operating at a loss in 2013 due to the manufacturing difficulties.
The FDA approved Covidien's fixes to the manufacturing process of its recalled Pipeline Embolization Device and Alligator Retrieval Device for treating brain aneurysms.
The Internal Revenue Service is having just as much trouble deciphering the Affordable Care Act as the general public. The Act levies a 2.3% tax on medical device companies, but the IRS reports that it believes it is only collecting 76% of tax owed.
In an effort to bring clarity to the jargon-laden topic of unique device identification, the FDA released a straightforward, question-and-answer style guidance yesterday that tackles how to understand the requirements.
Baxter is doubling down on diabetes, not a bad bet to make given the global proliferation of the disease and its own overwhelming demand for dialyzers. The company is investing almost $300 million and hiring 200 people to expand its hemodialysis manufacturing in Opelika, AL.
Amid a sea of companies creating mobile medical devices, a Philadelphia startup hopes to set itself apart and deliver an innovative product that provides quick, at-home lab diagnostics on a smartphone.
Further concentrating life science powerhouses around Boston, GE Healthcare Life Sciences will open a new U.S. headquarters in Marlborough, MA. It's expected to house more than 500 employees, including at least 220 new hires.
Democratic Sens. Chuck Schumer and Kirsten Gillibrand of New York urged the FDA to remove all power morcellators from the market in a letter to FDA Commissioner Margaret Hamburg.
Covidien and Medtronic announced more than 45 people will join a newly created team to tackle integration issues during their merger.
The argument for the importance of patient diagnosis often relies upon the efficacy of subsequent treatment. But according to a recent study, three-quarters of people would want to know if they have a particular neurological disorder even if it had no cure.
ConvaTec is weighing plans for a corporate inversion deal as interest builds from larger companies looking to cash in on the med tech M&A trend.
Boston Scientific has just announced plans to launch new fractional flow reserve and atherectomy guidewires in 2015 in collaboration with Japanese medical component specialist Asahi Intecc.
Medtronic has tied its long-term growth to three pillars: strong U.S. sales, double-digit growth in emerging markets and Covidien. But last quarter, the medical device giant didn't deliver on emerging market revenue growth as it encountered difficulties with distributors in India and China. It expects to return to double-digit gains in both countries this fiscal year.
Venture Capital firm Rock Health announced today that it is adding 8 digital health companies to its portfolio and partnering with three industry bigwigs, including Abbott.
Chemisense is developing an updated air-quality monitor and correlating smartphone app that will identify areas with heavy pollutants and irritants for users, as well as crowdsource the data users collect.
The federal Patient-Centered Outcomes Research Institute added three medical device-related topics to its list of priority research areas that are eligible for enhanced funding under the Pragmatic Clinical Studies initiative. In the new funding round, comparative trials studying cardiology, hip fracture and surgical mesh are invited to apply.