FDA approved high-risk women's health devices without proper data: Study
Some high-risk women's health devices were approved without proper data, according to a recent study. The findings point to a need for increased oversight from the agency, researchers said.
Let's make a med tech deal: J&J, Medtronic, Apple, Google sit on piles of cash
Med tech is attracting a huge range of strategic investors right now. Healthcare is almost universally recognized as in need of rationalization--the application of technology in the effort to achieve better outcomes at lower costs. Medical devices and diagnostics, and the data that they generate, are expected to be central to achieving that goal in the coming decades. Read more >>
J&J to enter structural heart devices, details Verb strategy in robotic surgery
Johnson & Johnson laid out its plans to turn around its medical device business--pledging annual growth for it of about 4% to 6% through 2020. To drive that, it's looking to further enhance its fastest growing market segments--such as electrophysiology and neurovascular--while getting to market in surgical robotics and entering structural heart devices, the company told investors on May 18. Read more >>Medtronic defends handling of Infuse bone graft study to probing lawmakers
Medtronic never intended to hide a study showing serious side effects linked to its Infuse bone graft, the company said in letters to two inquiring lawmakers. The company's response comes a month after reports showed that Medtronic pulled the plug on a study of its Infuse bone graft and allegedly buried the evidence. Read more >>
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Endo strikes back at medical funders in vaginal mesh cases: Reuters
Endo has agreed to shell out billions to settle most of the cases claiming injuries from its vaginal mesh devices. But don't expect the company to pay inflated damages for women who were encouraged to pursue unnecessary removal surgeries, it said.
NIH presents prize to startup for real-time, wearable alcohol biosensor
The National Institute on Alcohol Abuse and Alcoholism (NIAAA), which is part of the U.S. National Institutes of Health, issued a research challenge in March 2015 for the creation of a noninvasive, wearable alcohol biosensor. The expectation is that such a device would be useful to researchers who typically have to rely upon self-reported alcohol consumption data--as well as to make consumer wearables that monitor alcohol consumption commonplace.
UCSD researchers create the first EKG patch to incorporate a biochemical sensor
Engineers at the University of California, San Diego, have staked a claim to being the first to create a wearable that can simultaneously monitor biochemical and electrical bodily signals. Their Chem-Phys patch simultaneously records both electrocardiograms (EKGs) and lactate, which is a biochemical marker that's a measure of physical effort.
Edwards scores victory against Neovasc in transcatheter mitral valve courtroom battle
Edwards Lifesciences' CardiAQ Valve Technologies scored a victory in a courtroom battle with a rival and former service provider that allegedly stole the company's trade secrets to develop its transcatheter mitral valves.
Philips nabs fifth major North American hospital deal in enterprise managed services effort
Royal Philips, like many major medical device and imaging players, is looking to secure sizable long-term deals with hospitals. The idea is not only to secure future Philips revenues but also to cement a partnership that could result in more fruitful efforts at value-based healthcare, thereby meeting one of the most profound hospital needs.
Stanford engineers design portable, at-home urine test to detect various diseases
Urine tests are a staple at the doctor's office, but take time, cost money and can pile up quickly. Good news: Stanford University engineers are working on a low-cost, portable version of the test to ease the burden on doctors and clinics.
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A study this week called out a majority of marketers for violating FTC native advertising rules, noting that only one-third use the proper labels.
KaloBios has pledged a fair pricing oath, but with pricing continuing to dog the entire industry, will other pharma companies consider similar moves?




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