FDA Clearance for The Solero Microwave Tissue Ablation System Announces AngioDynamics

mJOULE Launches in the United Kingdom Reports Sciton

"Sciton is dedicated to worldwide support and growth. We continue to demonstrate our commitment to developing high quality devices and marketing efforts for our physician and medspa partners worldwide." says Lacee J. Naik, Vice President of Marketing and Public Relations.

FDA Issues Draft Guidance on Remanufacturing and Discussion Paper Seeking Feedback on Cybersecurity Servicing of Medical Devices

With this in mind, the FDA is issuing today's draft guidance to help clarify whether activities performed on medical devices are likely remanufacturing as well as a discussion paper on cybersecurity servicing of devices.

Irrimax Receives FDA Clearance for Irrisept

"This new clearance from the FDA further solidifies Irrisept as the market leader in wound irrigation," said Mark Alvarez, CEO of Irrimax.

AngioDynamics (Nasdaq:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease and oncology/surgery, today announced the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Solero Microwave Tissue Ablation (MTA) System. The Solero MTA System and Accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.

“The U.S. market has been asking AngioDynamics for a solid state, simple, fast, portable and scalable single applicator microwave system,” said Rick Stark, Senior Vice President and General Manager of the Oncology/Surgery division of AngioDynamics. “The launch of the Solero in the U.S. will fulfill our commitment to physicians and provide them the innovative tools they have been asking for in the ablation of soft tissue.”

The Solero MTA System features the Solero Microwave (MW) Generator and the specially designed Solero MW Applicators. The solid state Solero MW Generator with a 2.45 GHz operating frequency can power up to 140 W for optimized power delivery and fast ablations. The Solero MW Applicator’s optimized ceramic tip diffuses MW energy nearly spherically, and its patented cooling channel with thermocouple provides real-time monitoring to help protect non-targeted tissue ablation. In addition, the Solero MTA System offers physicians scalability with a single applicator designed for multiple, predictable ablation volumes by varying time and wattage.

spot_img

DON'T MISS

Hyperfine Adds Medtech Leader and Visionary Scott Huennekens as Executive Chairman

Mr. Huennekens’ public boards include Chairman of Acutus Medical (IPO August 2020); Chairman of Envista (IPO September 2019); and board member of Nuvasive. He also serves as a board member and past Chairman of the Medical Device Manufacturer’s Association (MDMA).

One Drop Reports Carrie Siragusa, CPA Appointed VP of Commercial Strategy, Biosensor

Formerly Head of Innovation and Diabetes Portfolio at Sanofi, Siragusa will be part of a team bringing a multi-analyte dermal sensor (biosensor) with continuous health sensing capabilities to market with a mission to provide broader access to continuous glucose monitoring.

Barbara Moorhouse Appointed as Medica Non-Executive Director

Barbara has extensive business and management experience in the private, public, and regulated sectors.

Subscribe to Medical Device News Magazine here.

Related Articles