Yesterday morning, the FDA published its 17-page first draft of a working model for its pre-certification program for software as a medical device (SaMD). Though still preliminary (the agency is asking for comments by the end of May), the publication comes with some long-awaited details about how the program might work.
When Parachute Health founder and CEO David Gelbard’s father was discharged from the hospital following spine surgery, the hospital ordered a walker to assist him as he recovered. But for weeks, it didn’t arrive and Gelbard’s father subsequently fell, adding years to his rehabilitation.
SafeHeal, an early-stage medtech company specialized in digestive surgery and focused on the development of the Colovac device, announces today that it has closed a €6 million Series A financing round led by Sofinnova Partners.
Oxford Performance Materials, a company whose materials have been used in everything from medical implants to Boeing airplanes, has been given the green light to distribute its 3D printed medical devices in Japan, paving the way for major expansion within Asia.
On Feb 27th, China Food and Drug Administration (CFDA) published their inspection reports for eight international medical device manufacturers located in U.S., Europe, Japan, and Australia under its Medical Device Good Manufacturing Practice.
Moody’s Investors Service has upgraded the financial outlook for the medical products and device industry from stable to positive, predicting that “continued product innovation” and synergies from acquisitions will drive growth of earnings before interest, depreciation and amortization (EBITDA) of between 4 and 5 percent over the next 12 to 18 months.
Panther Orthopedics has won FDA approval for its implantable orthopedic fixation device. The 510(k) nod clears Panther to sell a device designed to deliver continuous compression during bone healing while allowing joint motion.
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