BOSTON, MA / ACCESSWIRE / May 8, 2024 / Freyja Healthcare, an early-stage medical device company focused on developing a robust product portfolio of highly innovative products for women’s health, today announced that its novel VereSee device received 510(k) clearance from the United States Food and Drug Administration (FDA). Clearance from the FDA marks a critical step in enabling Freyja and VereSee – the first and only 2mm, safe abdominal-access video-entry device for laparoscopic surgery – to bring further innovation in the fast-growing women’s health market. VereSee will reinvigorate a category that has not seen innovation in over three decades.

Founded by Jón Ívar Einarsson, MD, PhD, MPH, and Gaby Moawad, MD, FACOG, Freyja’s mission is to raise the standard of women’s health in both surgical and in-office procedures, enabling physicians to deliver safe and effective care. As the company’s first novel product, the VereSee device features a proprietary design engineered to be simple for the surgeon, safe for the patient, and highly differentiated from the current standard of care. The company now has four products in advanced stages of development, 17 granted patents and 21 pending patents.