Misonix, a US-based minimally invasive ultrasonic medical devices provider, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its ultrasonic surgical platform Nexus.
Image: Misonix has received US FDA clearance for its ultrasonic surgical platform Nexus. Photo: Courtesy of The U.S. Food and Drug Administration/Wikipedia.
Misonix, wihch designs, manufactures and markets ultrasonic medical devices for the precise removal of hard and soft tissue, is expected to start commercialization of the Nexus platform in the US in July 2019.
Nexus is an advanced, integrated ultrasonic surgical platform designed to integrate all the features of Misonix’s existing solutions.
The new platform combines the BoneScalpel, SonicOne and Sonastar solutions into a single platform, and is also intended to help the future solutions.
Misonix president and chief executive officer Stavros Vizirgianakis said: “We are very pleased to have achieved this critical approval, marking a significant milestone for Misonix and the culmination of years of hard work.
“Nexus is a powerful, highly integrated and easy-to-use system that will benefit both healthcare providers and patients by incorporating the latest advances in ultrasonic technology allowing for increased efficiency and efficacy, and thus improved outcomes. It is truly a transformational product.
The Nexus platform is based on the company’s new innovative digital algorithm that results in more power, efficiency and control.
In addition, the new platform incorporates RF capabilities, facilitating its use in general surgery procedures and incorporates Smart Technology, for easier setup and use.
The company claims that its Nexus platform enables physicians utilize its increased power to improve tissue resection rates, along with its unique digital algorithm to achieve more effective bone removal procedures.
In addition, the platform’s ease of use allows physicians to completely leverage its capabilities through its digital touchscreen display and smart system setup.
Vizirgianakis added: “The overwhelmingly positive feedback we have received from the surgeon community since first unveiling Nexus reinforces our confidence in its potential to serve as a significant growth engine for Misonix. Nexus is a key component of our strategy to increase our presence in the neuro, spine, ortho, wound and general surgery markets.
“Nexus provides us with a unique 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.”