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The FDA said Friday that it is withdrawing guidance it issued in June 2020 — three months after the beginning of the pandemic — on formal meetings and user fee applications for devices. The withdrawal is effective July 7. Read More
3DBio Therapeutics, a New York-based regenerative medicine company, and the Microtia-Congenital Ear Deformity Institute in San Antonio, Texas, have partnered to reconstruct a human ear using the company’s AuriNovo 3D-bioprinted implant. Read More
The FDA has issued final guidance that details what information should be included in premarket submissions to show electromagnetic compatibility (EMC) for electrically powered medical devices and medical devices with electrical or electronic functions and sensors. Read More
Surgeons can use the sutures for other soft tissue procedures where a knotless anchor is suitable, including in the foot and ankle, the company said. Read More
Helsinki, Finland-based Bioretec’s bioresorbable Activa IM-Nail was effective in treating pediatric forearm fractures in an ongoing postmarket study by European researchers. Read More
The FDA’s Center for Devices and Radiological Health (CDRH) said it is now accepting all presubmissions for in vitro diagnostics (IVDs), including non-COVID-19-related products, effective June 1. Read More
Novela Neurotechnologies, a digital health company that specializes in epilepsy care, has acquired a portfolio of seizure-monitoring devices through the purchase of Brain Sentinel’s intellectual property, including 58 patents and applications. Read More