Indian femtech company Nesa Medtech has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Fibroid Mapping Reviewer Application (FMRA). The Software as a Medical Device (SaMD) creates a 3D model of the uterus from ultrasound images, helping physicians diagnose and plan treatments for patients with symptomatic uterine fibroids.
Uterine fibroids, also known as leiomyomas, are non-cancerous growths affecting one in four women. They can cause excessive menstrual bleeding, pelvic pain, and infertility, severely impacting a patient’s quality of life. Nesa’s FMRA technology allows doctors to determine the exact location and size of the fibroids, vital information for deciding the most effective surgical approach.
“While uterine fibroids are extremely common, for some patients they can be extremely painful and require intervention,” commented John Petrozza, MD, Department of Obstetrics and Gynecology at Massachusetts General Hospital and Co-Director of the Integrated Fibroid Program. “Nesa’s FMRA technology allows physicians to determine fibroid location and dimensions, critical details for effective minimally invasive image guided treatment planning.”
“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.”