inHEART, a privately-held medical device company delivering the world's most advanced, AI-driven digital twin of the heart, announced today that it has received FDA...
Ventris Medical recently received FDA 510(k) clearance for its Amplify standalone bone graft putty in the intervertebral disc space.
The Newport Beach, California-based company designed...
The US Food and Drug Administration (FDA) has granted clearance to Cosm Medical for its Gynethotics Pessaries for pelvic floor disorders.
The current gold standard...
The US Food and Drug Administration (FDA) has awarded breakthrough device designation for Bioretec’s RemeOs Spinal Interbody Cage implant, marking a significant advancement in...
SetPoint Medical announced today that received FDA breakthrough device designation for its novel neuroimmune modulation platform.Valencia, California–based SetPoint designed its nerve modulation technology for...
US-based bioelectric medicine company Pulse Biosciences has received the US Food and Drug Administration (FDA) 510(k) approval for its CellFX nsPFA (nanosecond pulsed field...
A US Food and Drug Administration (FDA) panel has issued a positive recommendation for Lumicell’s surgical imaging tool for breast cancer detection.
The FDA’s Medical...
SurGenTec announced today that it received FDA 510(k) clearance for its OsteoFlo HydroPutty synthetic bone graft.OsteoFlo HydroPutty follows the company’s OsteoFlo NanoPutty, which received...
Stéphanie Hilbold, director of quality assurance and regulatory affairs at RDS, said: “Achieving this pivotal milestone is testament to the hard work of our...
