"BD secures FDA 510 (k) clearance for EnCor EnCompass system" was originally created and published by Hospital Management, a ...

CapsoVision, Inc. CV recently announced that it has submitted a 510(k) application to the FDA for approval to add an AI-based reading feature to its CapsoCam Plus capsule endoscopy system. The ...

From softwares to implants, here are 10 spine products earning FDA nods since May 15. 1. Accelus’ FlareHawk interbody fusion device was FDA-cleared for use in MRI scanning under certain conditions.

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 ...

Diabeloop receives FDA 510(k) clearance for DBLG2, an Automated Insulin Delivery algorithm in an App: a strategic ...

Please provide your email address to receive an email when new articles are posted on . The device is the first to gain FDA clearance to monitor delirium. The device’s algorithm was validated with ...

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 ...

(RTTNews) - Apyx Medical Corporation (APYX), an advanced energy technology company, announced on Monday that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration ...