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July 24, 2023
Nesa Medtech’s Fibroid Mapping Reviewer Application Cleared by FDA
July 24, 2023—Nesa Medtech, a private medical device company based in India focused on the treatment of symptomatic uterine fibroids, announced that it received 510(k) clearance from the FDA for the company’s fibroid mapping reviewer application (FMRA).
According to the company, the FMRA technology is intended for use by physicians to generate a three-dimensional model of the uterus from ultrasound images to assist in the accurate diagnosis and planning of interventional procedures for patients with uterine fibroids.
“While uterine fibroids are extremely common, for some patients they can be extremely painful and require intervention,” commented John Petrozza, MD, in the company’s press release. “Nesa’s FMRA technology allows physicians to determine fibroid location and dimensions, critical details for effective minimally invasive image-guided treatment planning.”
Dr. Petrozza is with the Department of Obstetrics and Gynecology at Massachusetts General Hospital in Boston, Massachusetts, and Codirector of the hospital’s Integrated Fibroid Program.
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