The FDA posted online 510(k) approval for Sonoma Pharmaceuticals (SNOA)’ Microdacyn Hydrogel, which is intended for use of acute and chronic wounds, ulcers, cuts, abrasions and burns healing. The ...

The US Food and Drug Administration (FDA) has granted a second 510(k) clearance to expand the use of Respiree’s RS001 cardio-respiratory wearable to home-based settings. The clearance includes ...

CurveBeam has announced it has received FDA 510(k) approval for pedCAT, an in-office 3D foot and ankle scanner, according to a news release from CurveBeam. pedCAT uses cone Beam Computed Tomography ...

CAMPBELL, Calif.--(BUSINESS WIRE)--Simpson Interventions, Inc., a pioneering medical technology company, specializing in cardiovascular interventional devices, today announced achievement of major ...

Cloud-Based System, Featuring Wearable Biosensor with Chest-Based SpO 2, Enables Active Patient Monitoring Across Hospital and Out-of-hospital Care Settings Replaces time-consuming manual spot ...

Lumenis, an Israel-based medical laser company for ophthalmic and surgical applications, received FDA 510(k) clearance for the ResurFX, a fractional non-ablative laser module. The ResurFX is part of ...

Apyx Medical submits FDA 510(k) for AYON Body Contouring System, an innovative solution for comprehensive fat removal and skin tightening. Apyx® Medical Corporation has announced the submission of a ...