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...
EDAP TMS, a developer of invasive medical devices, has received the US Food and Drug Administration’s (FDA) breakthrough device designation for its Focal One...
Axena Health has announced that its Leva Pelvic Health System received a new Healthcare Common Procedure Coding System (HCPCS) Level II code from the...
AIOMEGA, a Texas biomedical company, announced that AIO BREATHE, their medical device that treats Obstructive Sleep Apnea, has been cleared by the Food and...