For most of the last five years, a spine implant with an FDA breakthrough device designation had a reliable head start on Medicare payment. The designation was treated as proof that a device represented a substantial clinical improvement over existing…
Spinal Tech
The FDA approved Spineart’s Baguera C cervical disc for 1 and 2 contiguous levels, expanding the device’s availability in the U.S. The disc is designed as a motion-preserving option for patients with cervical disc disease, according to an Aug. 11…
ClearPoint Neuro, a medical device and therapy company, reported $10.9 million in revenue for the second quarter of 2026, up 18% year over year. Neurosurgery navigation and therapy revenue increased 62% to $5.6 million from $3.4 million, while biologics and…
Neuralytix, a spine medtech company, made its iD3 System fully commercially available Aug. 4 through its U.S. distributor network. The mechanomyography platform is designed to give spine surgeons real-time, objective feedback on neurophysiologic changes occurring throughout decompression surgery, according to…
Xtant Medical Holdings reported a $9.4 million net loss in the second quarter of 2026, compared with net income of $3.6 million during the same period in 2025. Here are five things to know from the company’s Aug. 11 financial…
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Elevation Spine received FDA 510(k) clearance for Saber-XA, an anterior lumbar interbody fusion system that combines an expandable cage with a zero-profile, FDA-cleared anterior lumbar plate. The system allows surgeons to independently adjust implant height and lordotic angle during surgery.…
Device and drug makers will lose the shortcut they have used to secure supplemental Medicare payments since 2020, under a provision of the fiscal 2027 Inpatient Prospective Payment System final rule. Beginning with applications for fiscal 2028, every applicant for…
The Q2 earnings season for 2026 is in the books for the orthopedics and spine sector, and the results paint a picture of a market still growing steadily despite tariff pressure, cyber-attack recovery costs and ongoing structural shakeups. Stryker Revenue:…
Globus Medical reported second-quarter worldwide net sales of $789.6 million, up 5.9% year over year, and raised its full-year non-GAAP diluted earnings per share guidance while reaffirming its 2026 revenue outlook. GAAP net income in Q2 fell 25.3% year over…
An Alabama woman sued Boston Scientific and Boston Scientific Neuromodulation, alleging one of the companies’ spinal cord stimulator systems caused injuries after it was implanted to treat chronic pain. The complaint was filed July 30 in the U.S. District Court…