The US Food and Drug Administration (FDA) has granted Noah Labs breakthrough device designation for a remote patient ...
An analysis of AI-powered devices that received FDA's "breakthrough" label shows a preference for big-picture, multi-problem ...
Compremium recently won FDA Breakthrough Device designation for its noninvasive Quantis CVP (central venous pressure) measurement device.
MicroPort NeuroScientific Corporation announced that the company’s Apollo Dream sirolimus target-eluting stent system has b ...
—Breakthrough Device Designation to streamline regulatory review and support a pathway toward broader reimbursement coverage— ANDOVER, Mass. and HAIFA, Israel, March 11, 2026 /PRNewswire/ -- MeMed, a ...
Nia Therapeutics announced today that it received FDA breakthrough device designation for its Smart Neurostimulation System ...
Designation highlights GeneDx innovation in clinical whole genome and whole exome testing and accelerates the pathway for FDA authorization of these novel diagnostic tests With more than 2.5 million ...
The FDA has granted Breakthrough Device designation to a blood test that differentiates between bacterial and viral infections.
Nia Therapeutics announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to its ...
FDA grants Breakthrough Device Designation to BioAgilytix’s anti-AAV antibody assay supporting Lexeo’s gene therapy for Friedreich ataxia. DURHAM, NC, UNITED ...
The FDA Center for Devices and Radiological Health (CDRH) granted Airiver Medical the Breakthrough Device Designation to expedite development of its Pulmonary Drug Coated Balloon (DCB) for patient ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results