Nesa Medtech’s Fibroid Mapping Reviewer Application Gains FDA Nod

Nesa Medtech, a company focused on symptomatic uterine fibroids, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Fibroid Mapping Reviewer Application (FMRA).
 
The FMRA can generate a 3D model of the uterus from ultrasound images, in order to help diagnose and plan interventional procedures for uterine fibroids.
 
“While uterine fibroids are extremely common, for some patients they can be extremely painful and require intervention,” John Petrozza, MD, Department of Obstetrics and Gynecology at Massachusetts General Hospital and Co-Director of the Integrated Fibroid Program, told the press. “Nesa’s FMRA technology allows physicians to determine fibroid location and dimensions, critical details for effective minimally invasive image guided treatment planning.”
 
Medication is only effective for a small percentage of uterine fibroid patients, and many need open surgery or minimally invasive procedures for treatment. The size and location of fibroids are critical to choose the right surgical approach.
 
“Receiving FDA clearance is a significant milestone and a proud moment for the company,” said Sreekar Kothamachu, CEO of Nesa Medtech. “I applaud the team’s efforts to reach this achievement, the first step towards our goal of delivering a novel and comprehensive minimally invasive image guided therapeutic solution that transforms care for patients with symptomatic uterine fibroids.”