The U.S. Food and Drug Administration has issued a safety communication regarding a wide array of intravascular implanted devices and delivery tools that have coatings designed to reduce friction and improve maneuverability.
Leveraging Big Data platforms is becoming increasingly important in the med tech realm, as companies know well. Technology giant Dell is wise to the trend and recently inked a deal with Israel's Zebra Medical Vision to get its hands on the company's data analytics platforms to flesh out its diagnostics and wellness services.
Swiss med tech player Debiotech has partnered to develop a next-gen artificial pancreas for diabetics with a pair of Swiss research centers. The aim is to improve upon the accuracy of automatic insulin delivery by using a microelectromechanical system (MEMS) to control the pump. It will be based on an algorithm designed to estimate patient needs based on their measured glucose levels, the time of day and anticipated activities to adjust the infusion rate from an insulin pump.
The FDA's drive to regulate the molecular diagnostics industry is gaining steam. It finally provided specific examples of problematic tests in a report to Congress. The agency has made several general statements about inaccurate diagnostics over the years without naming any specific tests or providers.
POPULAR COMMENT THREADS
Newly emerging med tech players large and small seem more apt to put women in the most plum executive spots--at least that's what our 2015 review of the top women in med tech anecdotally turned up.
Imaging company Dilon Diagnostics has landed a partnership to distribute a molecular breast imaging system from GE Healthcare in select, undisclosed global geographies. The offering is intended to complement Dilon's own molecular imaging offerings.
Abbott is promoting the health economics of its Supera Stent for peripheral artery disease, pointing to a yet-to-be-published study which found that the device is cost-effective because it reduces the need for interventions compared to competing therapies, like Medtronic's Protégé bare-metal peripheral stent and In.Pact Admiral drug-coated balloon.
Last month, Alphabet, née Google, said that it would give its new businesses plenty of breathing room as part of its reorganization, allowing startups including its Life Sciences division the freedom to operate more independently. But Alphabet also wants to make sure that its fledgling companies can bear the load themselves, so it's offering them a lesson in fiscal management.
Minneapolis' Entellus Medical announced FDA 510(k) clearance of its FinESS Endoscope to open narrowed sinus drainage paths in recurrent or chronic sinusitis patients.
Startup Xenios has zeroed in its platform of minimally invasive products to treat patients with heart and lung problems. Its latest addition is i-cor, a synchronized cardiac assist system that just received a CE mark for marketing in Europe. This makes it the first heartbeat-synchronized cardiac assist device for cardiogenic shock and high-risk interventions.
From Our Sister Sites
Novo Nordisk signed a deal with Ablynx worth up to €377 million ($400 million) to collaborate on so-called nanobodies, antibody fragments designed to split the difference between biologics and small-molecule drugs.
Amgen's multiple myeloma treatment Kyprolis finally won approval in Europe--and with competition heating up across the pond, the go-ahead couldn't have come at a better time.