Regulatory

Check out the latest Regulatory news being talked about today across the world.

1474 posts

Organogenesis Announces Successful FDA Meeting and Plan to File BLA for ReNu® for Knee Osteoarthritis Pain

December 15, 2025

Companion Spine Announces FDA Premarket Approval (“PMA”) of the DIAM™ Spinal Stabilization System for the Treatment of Degenerative Disc Disease (“DDD”)

byJosh Sandberg

December 15, 2025

Inside information: Bioretec has been granted FDA Breakthrough Device Designation status for its RemeOs™ DrillPin

December 15, 2025

Gad Medical Ltd. Receives Regulatory Approval to Start Sales of Ruthless Spine’s RJB Interoperative Angle Measurement Instrument in Israel, Marking Significant Expansion Following NASS Momentum

byJosh Sandberg

December 12, 2025

Mainstay Medical Announces Coverage Recommendation from the International Society for the Advancement of Spine Surgery (ISASS) for ReActiv8

byJosh Sandberg

December 11, 2025

Joint Preservation Innovations Announces FDA 510(k) Clearance for the Articulator™ Arthroscopic Bur — the First and Only FDA-Cleared Articulating Rotary Cutting Instrument

December 8, 2025

SpineGuard Obtains the Clearance of Three New PediGuard® Models in China

byJosh Sandberg

December 5, 2025

Catalyst OrthoScience Receives FDA 510(k) Clearance for Expanded Indications of the Fracture Shoulder System

byJosh Sandberg

December 3, 2025

CERAMENT® V application in the U.S. transferred to the De Novo process

byWill Sandberg

December 2, 2025

Court Filing Update: Gizmo Medical Founder and Former Life Spine CEO Vindicated After Court Dismisses Majority of Life Spine’s Claims and Company Withdraws Remaining Allegations

byJosh Sandberg

November 21, 2025