Becker's ASC

FDA Orders Postmarket Surveillance Studies on Spinal Surgery Dynamic Stabilization Systems

The U.S. Food and Drug Administration has ordered manufacturers of certain types of pedicle screw systems, called dynamic stabilization systems, to conduct postmarket surveillance studies to collect ...
ksn.com

EMPIRICAL SPINE COMPLETES FULL PREMARKET APPROVAL (PMA) SUBMISSION TO FDA FOR LIMIFLEX™ DYNAMIC SAGITTAL TETHER™

SAN CARLOS, Calif., Dec. 19, 2022 /PRNewswire/ -- Empirical Spine, Inc., a medical device company creating a new class of spinal implant, recently completed the final step in the U.S. Food & Drug ...
Morningstar

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

Companion Spine Announces FDA Premarket Approval (“PMA”) of the DIAM™ Spinal Stabilization System for the Treatment of Degenerative Disc Disease (“DDD”) DIAM™ Spinal Stabilization System is the first ...
Becker's ASC

Stem Cell Treatment & Minimally Invasive Spine Stabilization in Outpatient Surgery Centers: Q&A With Laser Spine Institute on New Procedures

Laser Spine Institute, based in Tampa, Fla., has launched two new surgical procedures to meet the needs of patients with back pain: RegenaDISC® and Minimally Invasive Stabilization. The two procedures ...