The US Food and Drug Administration (FDA) has granted 510(k) clearance for Nesa Medtech’s Fibroid Mapping Reviewer Application (FMRA).
Physicians can use the new application from Nesa for generating a uterus 3D model from ultrasound images.
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These images are expected to help precisely diagnose and help physicians plan interventional procedures for patients with uterine fibroids.
Massachusetts General Hospital’s Department of Obstetrics and Gynecology reproductive endocrinologist and Integrated Fibroid Program co-director John Petrozza said: “While uterine fibroids are extremely common, for some patients they can be extremely painful and require intervention.
“Nesa’s FMRA technology allows physicians to determine fibroid location and dimensions, critical details for effective minimally invasive image-guided treatment planning.”
Uterine fibroids, also referred to as leiomyomas, are non-cancerous tumours that affect one in four women.
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By GlobalDataThey may cause excessive menstrual bleeding, pelvic pain and infertility.
Given that medication is effective only for a little percentage of patients, many are required to undergo open surgery or even minimally invasive procedures.
Based on the size and location of the fibroid, physicians choose the appropriate surgical approach for each patient.
Nesa Medtech CEO Sreekar Kothamachu said: “Receiving FDA clearance is a significant milestone and a proud moment for the company.
“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.”
Nesa Medtech develops novel minimally invasive image-guided surgical solutions for the treatment of symptomatic uterine fibroids.
