Topic: FDA

NuVasive has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance […]

Siemens Healthineers (ETR:SHL) announced that it received FDA emergency use authorization (EUA) for its Clinitest COVID-19 […]

Cardiologs has won a nod from FDA for an AI-powered cardiac diagnostics platform for pediatric […]

Theradaptive announced today that it received FDA breakthrough device designation for its Osteo-Adapt SP spinal fusion […]

Medtronic (NYSE:MDT) announced today that it received FDA 510(k) clearance for its PillCam Small Bowel 3 […]

Vicarious Surgical (NYSE:RBOT) announced in its quarterly earnings report that it set its FDA regulatory process […]

Magnus Medical has announced that the US Food and Drug Administration (FDA) has granted the […]

Siemens Healthineers’ Varian is among the latest companies to receive FDA breakthrough device designation, securing the […]

Varian announced today that it received FDA breakthrough device designation for its Embozene microspheres for treating […]

Medtronic today announced it has received CE mark approval for its radial artery access portfolio, which includes […]

Novocure (NSDQ:NVCR) announced today that the FDA granted breakthrough designation for its NovoTTF-200T liver cancer treatment […]

FDA has granted breakthrough device designation to Endosound’s system to turn any flexible upper gastrointestinal […]

The company’s bioimpedance spectroscopy device would be used to measure how much fluid should be removed from a patient during dialysis. 

Royal Philips (NYSE:PHG) announced today that it initiated repair and replacement programs for its recalled sleep […]

Zimmer Biomet (NYSE:ZBH) and Canary Medical announced today that the FDA granted de novo classification for […]

The Stentrode motor neuroprosthesis, developed by Synchron, has taken another step towards becoming the world’s […]

The biggest medtech news of the week, in one minute or less.

Neuros Medical has received Breakthrough Device designation from the US Food and Drug Administration (FDA) […]

Genentech announced that the FDA accepted its Biologics License Application (BLA) for its Port Delivery […]

CoreLink has announced the commercial launch and 510(k) clearance from the US Food and Drug […]

Neo Medical has received US Food and Drug Administration (FDA) 510(k) clearance for the use […]

Spinal Stabilization Technologies (SST) has announced that it has earned the CE Mark and the […]

ChoiceSpine, a spinal device company based in Knoxville, USA, has announced that it has received […]

Varian announced today that it received FDA breakthrough device designation for its cardiac radioablation (CRA) system. […]

Digital mental health company Woebot Health has landed FDA Breakthrough Device Designation for its postpartum […]

South Korean medical robotics company CUREXO has announced that its spinal surgery robot, CUVIS-spine, has […]

The FDA today issued a draft guidance with recommendations for clinical trials for certain devices […]

Medicare coverage for FDA-designated breakthrough medical devices will have to wait several more months, despite […]

Neurodon announced today that it initiated studies to prepare an FDA Investigational New Drug (IND) […]

Bigfoot Biomedical announced today that it received FDA 510(k) clearance for its Bigfoot Unity diabetes […]

The US Food and Drug Administration (FDA) has authorised marketing of a new device indicated […]

Cerus Endovascular has announced that the US. Food and Drug Administration (FDA) has approved its […]

IpsiHand exoskeleton uniquely leverages brain-computer interface technology for chronic stroke rehabilitation IpsiHand also has been granted […]

BD (NYSE:BDX) said today that it has applied to the FDA for a new clearance […]

Intertek has won accreditation under an FDA pilot program for testing laboratories, the company said […]

Moleac has announced the approval of the US Food and Drug Administration (FDA) of an […]

The Food and Drug Administration is greenlighting AI tools at a faster pace, from computer […]

Genentech announced today that the FDA approved its supplemental biologics license application for the Xolair […]

A Covid-19 antibody cocktail developed by Regeneron Pharmaceuticals and Roche has pivotal clinical trial data […]