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Medical Devices / Submissions and Approvals

FDA Clears Misonix’ Ultrasonic Surgical System

June 5, 2019
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The FDA has handed Misonix 510(k) clearance for its Nexus ultrasonic surgical platform, which integrates multiple solutions for surgical applications into a single device.

The system combines all the features of the company’s ultrasonic tools—BoneScalpel, SonicOne and SonaStar—to enable bone, tumor and tissue removal capabilities. Nexus’ smart technology makes the platform easier to setup and use.

Nexus features a new digital algorithm that provides more control and efficiency, and increased power to improve tissue resection rates. Misonix will launch the platform on the U.S. market in July.

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