The number of breakthrough device designations granted by the FDA has seen a gradual increase and peaked in recent years, according to new data. The breakthrough device designation provides sped-up processes for development, assessment and review for clearance for selected…
Spinal Tech
Xenix Medical earned FDA 510(k) clearance for its Lux expandable lumbar interbody fusion system, and the device is available in a full commercial launch. The Lux system allows for significant post-expansion bone graft packing and features Xenix Medical’s NanoActiv surface,…
On the heels of strong sales in fiscal year 2026, Medtronic is placing high expectations on its new robotic system, leaders said in a June 3 earnings call. Rollout of Medtronic’s Stealth AXiS robot is going well with positive physician…
The U.S. Court of Appeals for the Federal Circuit on June 4 rejected Globus Medical’s last-remaining patent claim against Life Spine. In 2021 Life Spine was sued over allegations the ProLift line infringed Globus Medical’s patents, Life Spine said in…
Xenis Medical earned the FDA’s 510(k) clearance for the Riva posterior fixation system and launched the device, according to a June 2 news release. The system has a modular design and tulip head and screw shank options to address complex…
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Precision Spine launched its Reform Ti FS modular fenestrated screw system, according to a June 3 news release. The screw system is designed delivers PMMA bone cement through the screw shaft directly into the vertebral body. It can be used…
Aclarion partnered with the Institute of Neuro Innovation in Santa Monica, Calif., according to a June 3 news release. Amir Vokshoor, MD, who leads the institute, will use SPECT-CT and Aclarion’s Nociscan in conjunction to support physicians treating chronic lower…
Medtronic saw revenue growth in the fourth quarter and the full fiscal year 2026, which ended April 24, 2026, according to financial results posted June 3. Six things to know: 1. Quarterly earnings were $9.8 billion, an increase of 9.9%…
From new technology acquisitions to regulatory clearances to leadership changes, here are 20 developments and updates from the biggest players in the orthopedic and spine medtech space, as reported by Becker’s since April 1: Johnson & Johnson/DePuy Synthes Medtronic Smith+Nephew…
SurGenTec’s ION-C earned FDA 510(k) clearance for ION-C navigation instruments with the ION-C posterior cervical facet fixation implant, according to a May 29 news release. The system is designed for use with Medtronic’s StealthStation platform in cervical fusion procedures. ION-C…