The US Food and Drug Administration (FDA) has cleared Halt Medical's minimally invasive technology, designed for treating uterine fibroids.
The Acessa technology, which is designed for preserving the normal function of the uterus, features a slender handpiece for delivering radiofrequency energy to the fibroid.
Halt Medical president and chief operating officer Russ DeLonzor said the approval was based on the compelling results from three clinical studies.
"We’ve been expanding our manufacturing operations near San Francisco and are ready to meet the increased demand for Acessa from doctors in the U.S. and abroad," DeLonzor added.
Halt Medical chief executive officer Jeffrey Cohen said with the availability of Acessa, gynecologists will now have an alternative to hysterectomy for their fibroid patients.
"Acessa is the first product cleared anywhere in the world that can be used by gynecologists to treat all fibroid symptoms and types," Cohen added.
"The high patient satisfaction and low re-intervention rates seen in our clinical studies provides the opportunity for the healthcare system to replace radical surgery and save billions of dollars."