Leveraging big data and real-world evidence in regulatory decisions, enhancing medical device cybersecurity and streamlining clinical trial design are some of the top priorities identified…

AdvaMed warned the White House in a meeting August 8  that forthcoming regulations revising emission standards for ethylene production could endanger the medical device supply chain and patient safety if…

Apple has entered into an agreement with Allscripts to allow its Apple Health Records product to interface with many of Allscripts’ electronic health record products…

Medicare contractors published a batch of local coverage determinations Thursday relating to devices and diagnostics sold by companies including Myriad Genetics and…

Enable Injections said yesterday that it entered a developmental partnership with Genentech for the Enable enFuse device…

Edwards Lifesciences (NYSE:EW) shares slid today after the FDA slapped Class I status on last month’s recall of its Sapien 3 Ultra…

The Ahmed ClearPath device, named after the Rancho Cucamonga, CA-based company’s founder Dr. A. Mateen Ahmed, helps drain intraocular pressure…

MedTech analysts continue to keep a watchful eye on the private sector. Needham & Co.’s Mike Matson just called attention to these five private medical device companies he finds interesting, adding to two previous lists the firm published earlier this year…

Miracor Medical said today that it received breakthrough designation from the FDA for its PiCSO device for treating a type of…

The medical device industry strongly criticized aspects of the European Commission’s draft policy on the reprocessing of single-use products in a slate of comments on the proposal this week…

MENLO PARK, Calif., Aug. 22, 2019 /PRNewswire/ — Drawbridge Health today announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the…

In 1999, the US Food and Drug Administration approved rapamycin as an immunosuppressant to prevent the rejection of…