In med tech, here are the top 10 news stories of the year so far, based on web traffic.
Japan begins regulating medical devices separately from drugs, aims to approve them faster than U.S.
Industry applauded Japan's initiative to create a medical device regulatory regime distinct from that for pharmaceuticals.
Some patients with cochlear implants feel pain during an MRI that is strong enough to prevent them from completing the procedure, a recent study in the Journal of the American Medical Association shows.
Boston Scientific has invested in Iowa Approach, a new startup devoted to its novel atrial fibrillation (AF) ablation technology. The technique is expected to be easier and cheaper than the current AF ablation procedures; there are about 400,000 ablations to treat AF annually. The company expects to be ready for testing in humans in 2016.
Laboratory Corporation of America Holdings and Envision Healthcare Holdings have invested $15 million in a Series B in Vivify, a startup focused on patient engagement and remote patient monitoring.
The battle is heating up over the FDA's draft guidance on the oversight of lab-developed tests, says the FDA Law Blog, which detailed both sides' actions over the last couple of weeks.
Replacing worn out ankle joints with new and improved devices appears to be gaining ground on knee and hip replacement procedures, though recipients may have to repeat the surgery at least once more in their lifetime.
In its annual 10-K filing with the SEC, Covidien quietly noted that it is under a federal subpoena related to some of its peripheral vascular products.
Silk Road Medical has disclosed positive, pivotal data for its Enroute Transcarotid Neuroprotection System to reduce the risk of stroke. The device had the lowest stroke rate in any study of a carotid angioplasty and stenting device in a prospective trial, according to the company.
A bill circulating the halls of Congress would limit the FDA's oversight of electronic health records and clinical decision support software, but may not have much practical effect since the agency limited its role in the regulation of software in a June draft guidance.
Bayer hopes to sell its ailing diabetes device unit to help bolster growth and fund a potential acquisition of Zoetis. The conglomerate would like to focus more closely on medicines, which has been a faster growth area than devices.
Covidien today announced FDA 510(k) clearance for its Fortrex percutaneous transluminal angioplasty balloon catheter, designed to maintain arteriovenous access in hemodialysis patients suffering from chronic kidney disease or end-stage renal failure.
Researchers at Tufts University have come up with a resorbable electronic implant that when used in mice was able to be triggered remotely by wireless signal and deliver heat to infected tissue.
NxStage Medical is primarily focused on the at-home dialysis market, but its newest product is devoted to making dialysis treatment in centers easier and faster for providers. It has launched the Streamline Express dialyzer that includes a preattached tubing set expected to reduce machine setup time and potential sites for contamination.
An early-stage study funded by the National Institutes of Health found that diagnosis of autism based on video taken using an in-development smartphone app concurred with diagnosis using traditional, in-person methods 87% of the time.
Amid growing backlash over tools used in minimally invasive gynecological procedures, the FDA is cracking down on the devices in updated safety guidance.
Reva Medical has raised $25 million in debt from Goldman Sachs and Senrigan Capital. The financing had been months in the making and is expected to enable the development-stage company to get its latest bioresorbable stent on the market in Europe.
The clock is about to strike 6 months since Stryker expressed interest in acquiring Smith & Nephew, only to be dissuaded by a rise in that company's stock price once news of the potential deal broke out. And so begins the speculation that Stryker will actually make a bid on the fellow orthopedics company this time around.
The FDA approved Avantis Medical's colonoscopy imaging device that is capable of showing a wide-angle image of more than 300 degrees during colorectal cancer screening procedures.
Tandem Diabetes Care, the maker of the t:slim insulin pump, has partnered with open-source software provider Tidepool. The deal is expected to better enable diabetes patients using the pump to download and access data from their device.