NESA MEDTECH RECEIVES U.S. FDA CLEARANCE FOR ITS FIBROID MAPPING REVIEWER APPLICATION (FMRA)
BENGALURU, India, July 24, 2023 /PRNewswire/ -- Nesa Medtech (Nesa), a private medical device company addressing clinical unmet needs for patients with symptomatic uterine fibroids, announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the company's Fibroid Mapping Reviewer Application (FMRA). The technology is intended for use by physicians to generate a 3D model of the uterus from ultrasound images to assist in the accurate diagnosis and planning of interventional procedures for patients with uterine fibroids.
- BENGALURU, India, July 24, 2023 /PRNewswire/ -- Nesa Medtech (Nesa), a private medical device company addressing clinical unmet needs for patients with symptomatic uterine fibroids, announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the company's Fibroid Mapping Reviewer Application (FMRA).
- "Receiving FDA clearance is a significant milestone and a proud moment for the company," said Sreekar Kothamachu, CEO.
- "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.