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.

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

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 ...

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 ...

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 ...

The "Intro to Medical Device Submission - 510(k)s, PMAs & Exemptions (Oct 9, 2025)" training has been added to ResearchAndMarkets.com's offering. The regulation and control of new or substantially ...

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 ...

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 ...

(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 ...

We were unable to process your request. Please try again later. If you continue to have this issue please contact [email protected]. BrainsWay Deep TMS is cleared for use by adolescents and ...