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.
Harvard researchers have developed an inexpensive handheld device for use in the world's poorest regions that can monitor diabetes, detect malaria and analyze drinking water through electrochemical analysis and then send the information to a computer anywhere on the globe by standard mobile phone.
Amid an influx of cyberattacks on med tech outfits and affiliated companies, one of the nation's largest hospital groups revealed that it was the target of external hackers.
Big Pharma is interested in partnering with startup electroCore on commercializing its noninvasive vagus nerve stimulation therapy for migraines and cluster headaches upon FDA approval, company CEO JP Errico says. In a sign that talks may be heating up, electroCore has appointed investment bank Piper Jaffray to advise it.
Abbott Laboratories and the United States Department of Defense are collaborating to develop a test that can be used to assess potential concussions quickly in the field. Abbott's handheld diagnostic i-Stat System is already in use by the military; the test will be developed for use on it.
Speculation is building that Minneapolis-based Medtronic will modify its offer for Dublin-based Covidien.
Global med tech companies could soon face mounting competition in China, as the country's top health authority is calling for a new set of initiatives to promote homegrown products and jumpstart the domestic industry.
The FDA continued its attack on Enhancement Medical LLC's Expression intranasal splint, designating the product's July recall as Class I.