Pulse Biosciences (Nasdaq:PLSE) announced today that the FDA granted breakthrough device designation for its pulsed field ablation system. Shares of PLSE rose more than...
Medical imaging company Avicenna.AI has secured Medical Device Regulation (MDR) certification for five of its AI algorithms which are used to screen severe conditions.
Avicenna.AI’s...
Signum Surgical has secured De Novo clearance from the US Food and Drug Administration (FDA) for its BioHealx technology for anal fistula treatment.
BioHealx is...
Brain-computer interface (BCI) developer Paradromics announced today that the FDA accepted it into its Total Product Life Cycle Advisory Program (TAP). TAP provides early...
Epica International has announced an updated 510(k) clearance from the US Food and Drug Administration (FDA) for its See Factor CT3 System.
This clearance signifies...
IceCure Medical announced the FDA granted clearance for its next-generation single-probe cryoablation system. The XSense cryoablation system with CryoProbes received clearance for all indications...
CeQur announced recently that the FDA granted 510(k) clearance for its Simplicity system for an extended wear duration. Clearance extends the wear time for...
The US FDA has given the green light for metabolic therapeutics company, Fractyl Health, to expand the REVITALIZE-1 clinical study for its endoscopic device...
Endotronix today announced it received FDA premarket approval for its Cordella PA Sensor System. The Naperville, Illinois=based company designed the Cordella Pulmonary Artery (PA)...
