New Delhi (India), July 27: In a major stride towards improving women’s healthcare, Nesa Medtech, a prominent startup in women’s health, has announced that its groundbreaking Fibroid Mapping Reviewer Application (FMRA) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The FMRA technology represents a significant advancement that will aid physicians in planning minimally invasive image-guided treatments for uterine fibroids.
Uterine fibroids, a common medical condition affecting women, often cause symptoms such as heavy menstrual bleeding, pelvic pain, and infertility. FMRA technology device is intended to generate a 3-D model of the uterus of women with uterine fibroids using ultrasound images. The innovative FMRA technology employs an advanced image processing algorithm to post-process 2D volume ultrasound images of the uterus, generating a comprehensive 3D model of the uterus. This 3D model provides critical clinical insights, including the location and dimensions of fibroids.
Speaking about the FDA clearance, the founder, Mr. Sreekar Kothamachu said, “We are thrilled to receive 510(k) clearance from the US FDA. This milestone further validates NESA’s quest to build devices of high quality & world-class solutions from INDIA.” Sreekar Kothamachu, the CEO & founder of Nesa Medtech, boasts over 15 years of professional experience working in reputed healthcare companies, such as Siemens and Philips healthcare. Recognizing the impact of uterine fibroids on one in every four women, he was motivated to develop a novel approach to providing innovative, minimally invasive device technology & solutions.
The FMRA’s clearance is expected to have a profound impact on the treatment offered for uterine fibroids, leading to the development of subsequent devices offering minimally invasive treatment options to patients with symptomatic uterine fibroids. By providing accurate and detailed information on fibroid location and dimensions, physicians can tailor treatment plans to suit each patient’s unique condition, improving overall outcomes and patient satisfaction.
Welcoming the FDA 501(K) clearance for Nesa’s solution, C-CAMP Director and CEO Dr Taslimarif Saiyed said, “Women’s health is a top priority for any universal healthcare program across the globe. We are delighted that with this nod from FDA, Nesa’s FMRA technology, as an indigenous Make in India story is a resounding success for India’s indigenous medical technology sector.”
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