Misonix Gains FDA Clearance for Nexus Ultrasonic Surgical Platform

By Julie A. Vetalice

Misonix Gains FDA Clearance for Nexus Ultrasonic Surgical Platform

Misonix received FDA 510(k) clearance to market the Nexus ultrasonic surgical platform. Commercial U.S. launch will commence next month.

Nexus combines all features of the company's existing products, including BoneScalpel, SonicOne and Sonastar, into a single fully-integrated offering driven by a proprietary digital algorithm that results in enhanced power, efficiency and control. RF capabilities support use in general surgery procedures, and Smart Technology enables ease of setup and use.

Physicians will be able to utilize Nexus’ increased power to improve tissue resection rates, in concert with its proprietary digital algorithm to perform more efficient bone removal procedures.

Stavros Vizirgianakis, President and Chief Executive Officer of Misonix, commented, “Nexus is a key component of our strategy to increase our presence in the neuro, spine, ortho, wound and general surgery markets, [providing the] opportunity to leverage our robust consignment business model, further drive the sale of consumables competitively, and extend our ability to cross-sell into multiple physician specialties. The commercialization of Nexus will expand the utilization of ultrasonic surgical applications as we continue to strategically invest in our products to become the standard of care in operating rooms and hospital outpatient departments.”

Source: Misonix, Inc.

Product Labels: Arthroscopy Equipment

Tags: 510(k) Clearance, Regulatory