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Bioventus Receives FDA 510(k) Clearance for SonaStar Elite
Innovative New Handpiece Addition to the Nexus Ultrasonic Generator Significantly Expands Company’s Offering in Neurosurgery Ablation Procedures DURHAM, N.C.,
About this update from Bioventus Inc.
[{"type":"text","content":"Innovative New Handpiece Addition to the Nexus Ultrasonic Generator Significantly Expands Company’s Offering in Neurosurgery Ablation Procedures DURHAM, N.C., Aug. 03, 2022 (GLOBE NEWSWIRE) -- Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a global leader in innovations for active healing, announced the US Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s neXus® SonaStar Elite® handpiece. The SonaStar Elite (SSE) handpiece is powered by the neXus Ultrasonic Surgical Aspirator System, a next generation integrated ultrasonic surgical platform driven by a proprietary digital algorithm resulting in more versatility and control. The neXus system combines all the features of soft and hard (including bone) tissue removal into a single fully integrated platform capable of operating at multiple frequencies, including the newly approved 36 kHz SonaStar Elite Handpiece. While the neXus system can be used in many clinical applications including neurosurgery, the SonaStar Elite handpiece has been cleared for resection of tumors with varying consistencies ranging from soft to firm, including the removal of malignant and benign brain and spinal tumors. \"The SonaStar Elite handpiece is the latest innovation in our neXus ultrasonic surgical pipeline,\" commented Andrew Hosmer, general manager, Surgical Solutions, at Bioventus. \"Bioventus has a proven history of developing differentiated and market-leading technologies, and we remain committed to pursuing safe and effective best-in-class products that meet the needs of our surgeons and improve outcomes for their patients.” About Bioventus Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations for Active Healing from Bioventus include offerings for pain treatment, restorative therapies and surgical solutions. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.bioventus.com, and follow the Company on LinkedIn and Twitter. Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC. BoneScalpel Access is a trademark and SonicOne, SonaStar and neXus a...