
FDA grants breakthrough device designation to SpinaFX’s Triojection system
The FDA has granted breakthrough device designation to SpinaFX Medical’s Triojection system, a minimally invasive treatment for contained lumbar disc herniations.

The FDA has granted breakthrough device designation to SpinaFX Medical’s Triojection system, a minimally invasive treatment for contained lumbar disc herniations.

Interventional Systems and HICREN today announced approval for their joint venture’s surgical robot platform in China.

PLANO, Texas, Aug. 7, 2025 /PRNewswire/ — ulrich medical USA, a leading medical device company focused on developing and commercializing spinal implant technologies, is proud to announce the full market launch of the Cortium® Universal OCT Spinal Fixation System, following a successful alpha release.

https://medtechspectrum.com/news/40/24634/mirus-secures-ntap-approval-from-cms-for-breakthrough-europa-cervical-spine-system.html

Carlsmed (Nasdaq:CARL) today announced new technology add-on payment (NTAP) reimbursement for its spine implant technology.

NAPLES, Fla., July 16, 2025 /PRNewswire/ — Arthrex, a global leader in minimally invasive surgical technology, announced that it has received U.S. Food and Drug Administration (FDA) clearance to use the Arthrex NanoScope™ operative arthroscopy system for pediatric orthopedics and laparoscopy.

OREM, Utah, July 10, 2025 /PRNewswire/ — Dymicron®, a privately held medical device company pioneering advanced spinal technologies, today announced that the United States (U.S.) Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to begin a pivotal clinical study of the Triadyme®–C cervical artificial disc.

Oxiplex is the only FDA authorized intraoperative gel indicated as an adjunct to lumbar spinal surgery to reduce postoperative leg pain and neurological symptoms.

Next-Generation Ankle Replacement Platform Designed to Improve Surgical Precision and Patient Outcomes in Orthopaedic Care

MOUNTAIN VIEW, Calif., June 18, 2025 /PRNewswire/ — Expanding Innovations™ (EI), a rapidly growing spine company specializing in NON-SCREW-based Expandable Technology, today announced U.S. FDA 510(k) clearance for its N-GAGE™ Lumbar Plate System—the company’s first spinal fixation platform as it continues to broaden its procedure-based solutions.