FDA clears Augmedics’ AR headset for use with spine surgery system
November 13, 2025
The company will introduce the headset at the North American Spine Society Annual Meeting in the US on 14 November.
The company will introduce the headset at the North American Spine Society Annual Meeting in the US on 14 November.
ALTSTÄTTEN, Switzerland and BOSTON, Nov. 13, 2025 /PRNewswire/ — icotec, the pioneer of implantable devices made from BlackArmor® Engineered Carbon/PEEK, today announced that the U.S. Food and Drug Administration (FDA) has cleared the CMORE® CT System for use in the cervicothoracic spine.
LISLE, Ill., Nov. 12, 2025 /PRNewswire/ — Hubly Surgical today announced FDA 510(k) clearance expanding Hubly Auto-Stop Drill indications to include spinal decompression procedures. To date, many thousands of neurosurgical patient lives have been saved using Hubly Auto-Stop Drills; the device’s SMART auto-stop halts rotation and prevents forward plunge at the instant of skull penetration, preventing over-drilling into patients’ brains. The new clearance expands use to laminectomy and laminotomy for spinal decompression to drill through the vertebral lamina and protect patients from damage to the spinal cord.
There’s a new tool in the hands of surgeons making waves in the world of hip arthroscopy.
DALLAS, Nov. 6, 2025 /PRNewswire/ — Dallas-based MedCAD has been awarded 510(k) FDA clearance for its AccuStride fixation plates, part of a patient-specific solution available to surgeons as a complete foot and ankle (F&A) system. The company received 510(k) FDA clearance for its foot and ankle guides and planning system in March 2025. The AccuStride implant and surgical guide system coupled with the company’s proprietary planning software will enable foot and ankle surgeons to correct multiple related pathologies in a single procedure.
Microbot Medical (Nasdaq:MBOT) announced today that it began the U.S. commercial launch of its Liberty endovascular surgical robot.
ORLANDO, Fla., Oct. 29, 2025 /PRNewswire/ — Optimotion Implants, a medical device company that designs and manufactures total knee replacement implants and associated surgical instrumentation is expanding operations in the Tampa Bay area. Optimotion Implants is the only company in the world utilizing the revolutionary Lateral Approach technique in total knee replacement. Participating surgeons are highly trained on the Lateral Approach which allows them to do what others cannot, leading to better outcomes for patients.
Zimmer Biomet (NYSE: ZBH)+
announced today that it received FDA breakthrough device designation for its iodine-treated total hip replacement system.
PARSIPPANY, N.J., Oct. 21, 2025 /PRNewswire/ — Onkos Surgical, a leading provider of innovative solutions for complex orthopaedic procedures, announced that it has recently received a 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ELEOS Proximal Tibia with NanoCept Antibacterial Technology. This marks the first 510(k) clearance for the NanoCept Antibacterial Technology since the original De Novo authorization was granted in April of 2024.
NextBiomedical this week announced it enrolled the first patient in its U.S. pivotal clinical trial evaluating its Nexsphere-F, a fast-resorbable microsphere for embolization treatment of musculoskeletal pain.