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Latest From SI-BONE, Inc.
Stryker received FDA 510(k) clearance for its Q Guidance System and Si-Bone received 510(k) clearance for the Granite spinal fusion implant.
Pfizer, Sanofi, Bristol Myers Squibb, Gilead’s Kite, Lilly’s Dermira, Janssen and Biogen among the major companies announcing transactions this week.
Results Recap: CRT In DC Features New Biotronik Stent Data, Encouraging TAVR Low-Risk Data; Ablative Systems’ Alcohol Renal Denervation
Medtech Insight's Results Recap covers major device trial results appearing on MedDeviceTracker. This week's edition, covering March 1 to March 7, includes results of late-breaking trials presented at the 2019 Cardiovascular Research Technologies (CRT) conference in Washington, DC, including new data supporting Biotronik’s biodegradable polymer sirolimus-eluting stent and the company’s resorbable magnesium stent, results of the LRT trial of transcatheter aortic valves in low-risk patients, plus promising clinical data supporting Ablative System’s alcohol renal-denervation system.
A top FDA device official says the agency is hoping to finalize an additive manufacturing guidance this year. Industry is particularly interested in seeing the leap-frog guidance made final, but would also like to see more clarification and a separate guidance to address the topic of patient-specific manufacturing.
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Surgical Equipment & Devices
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