FDA
-
Regulatory
FDA Grants Second Breakthrough Device Designation for Carlsmed Technology
CARLSBAD, Calif., September 20, 2023 — (BUSINESS WIRE)– Carlsmed announced today that the FDA granted Breakthrough Device designation for its…
Read More » -
Regulatory
DirectSync Surgical receives Breakthrough Device Designation from FDA for its Patient-Powered Smart Implants
LAWRENCE, Kan., May 02, 2023 (GLOBE NEWSWIRE) — DirectSync Surgical, a medical device company dedicated to improving the lives of patients…
Read More » -
Extremities
Pacira Announces FDA Acceptance of sNDA for Exparel Nerve Blocks to Produce Regional Analgesia in Lower Extremity Procedures
TAMPA, Fla., March 29, 2023 (GLOBE NEWSWIRE) — Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to…
Read More » -
Regulatory
Empirical Spine Completes Full Premarket Approval (PMA) Submission to FDA for LimiFlex™ Dynamic Sagittal Tether™
LimiFlex™ DST™ Is Designed for a New Class of Lumbar Stabilization Surgery That Meets the Demands of Value-Based Care. SAN…
Read More » -
Spine
Centinel Spine® Receives FDA Approval for 3 Additional prodisc® Cervical Total Disc Replacement Devices
Centinel Spine now has four PMA approved cervical Total Disc Replacement (TDR) devices, offering the broadest spectrum of solutions to…
Read More » -
Spine
3Spine, Inc. Announces IDE Approval
CHATTANOOGA, Tenn., June 22, 2022 /PRNewswire/ — 3Spine, Inc., a medical device company developing total joint replacement for the lumbar spine, today…
Read More »