3D modeling device receives FDA clearance to diagnose uterine fibroids

Key takeaways:

• The Fibroid Mapping Reviewer Application generates 3D models of the uterus from ultrasound.
• The device aids in diagnosis and planning of interventional procedures for uterine fibroids.

The FDA has granted 510(k) clearance to Nesa Medtech’s Fibroid Mapping Reviewer Application to aid physicians in diagnosing symptomatic uterine fibroids and planning of interventional procedures, according to a company press release.

“Receiving FDA clearance is a significant milestone and a proud moment for the company,” Sreekar Kothamachu, CEO of Nesa Medtech, said in the press release. “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.”

The Fibroid Mapping Reviewer Application generates 3D models of the uterus from ultrasound images to aid in accurate diagnosis of symptomatic uterine fibroids. This device also helps physicians with planning interventional procedures for women with symptomatic uterine fibroids.

“While uterine fibroids are extremely common, for some patients they can be extremely painful and require intervention,” John Petrozza, MD, chief of the division of reproductive medicine and IVF in the department of obstetrics and gynecology at Massachusetts General Hospital and co-director of the Integrated Fibroid Program, said in the release. “Nesa’s FMRA technology allows physicians to determine fibroid location and dimensions, critical details for effective minimally invasive image-guided treatment planning.”