Acessa Health said today it won FDA 510(k) clearance for its third-gen Acessa ProVu radiofrequency ablation system intended for use in treating symptomatic uterine fibroids.
The Austin, Texas-based company said the newly cleared system features ultrasound visualization and a guidance mapping system, and that it is intended to provide a safe alternative to hysterectomy procedures for women suffering from uterine fibroids.
“The FDA clearance of Acessa ProVu is a significant step forward in terms of offering patients more minimally invasive options to address their fibroids,” former US Surgeon General Dr. Regina Benjamin said in a press release.
“Acessa Health is delighted to usher in our next phase of innovation with the introduction of Acessa ProVu. Each phase of innovation – the original Acessa system, Acessa guidance system and now the Acessa ProVu system – represent a significant improvement in performance and the opportunity to further support our physician partners who help women suffering from uterine fibroid symptoms,” prez & CEO Kim Rodriguez said in prepared remarks.
In February, Acessa Health said that 32 state Medicaid programs now provide access to the company’s Acessa procedure designed to treat uterine fibroids using radiofrequency ablation.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.