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…

Atrial fibrillation, the fleeting arrhythmia of the heart, is hard to catch. Elusive and intermittent, it’s often overlooked during a seconds-long electrocardiogram …

Italian certification company IMQ is the fourth notified body designated under the European Union Medical Device Regulation, according to the European Commission Tuesday…

Avinger (NSDQ:AVGR) yesterday priced a stock offering worth nearly $5 million for its line of devices to treat…

Esteemed oral surgeons in Manchester, CT, Drs. Rosenlicht and Ansari offer Yomi® Robotic-Assisted Implant Surgery to enhance their dental implant placement…

Left ventricular assist devices (LVADs) have been shown to help leaky mitral valves that create significant regurgitation, but a new study questions the presumption that all’s well with the mitral valve after…

Myomo today said it launched a business development program to help bring its MyoPro orthotic product line to more markets…

Analysts and investors will get their first look at Medtronic’s soft tissue surgical robotics system late…

Singapore has enlisted Fitbit as a partner on a population health initiative meant to help improve overall health outcomes for the…

Medical devices are getting smarter. Contracting executives will have to do the same…

NuVasive (NSDQ:NUVA) yesterday announced the commercial launch of the Modulus TLIF-A, used in…

Teva (NYSE:TEVA) today announced that its FDA-approved generic EpiPen Jr. auto-injector is available…

AliveCor reportedly yesterday said that it ended sales of its KardiaBand for use with the Apple Watch…

Ultrasound imaging company Terason said today that it has inked a deal with y DiA Imaging Analysis to provide DiA Imaging’s cardiac solutions on…

Researchers at Ecole Polytechnique Fédérale de Lausanne in Switzerland have developed a new type of intraneural electrode to bypass the eyeball and send messages directly to…

The company EXO Imaging out of Redwood City, CA recently emerged from stealth mode to announce the development of a novel technology called Piezoelectric Micromachined Ultrasonic Transducers (pMUT) for…