VereSee By Freyja HealthCare Receives FDA Clearance, Pioneering Women’s Health Surgery

Freyja Healthcare, a pioneering medical device company with a focus on women's health, has achieved a significant milestone with the FDA's 510(k) clearance of its VereSee device. This innovative product, the first of its kind, offers a safer method for abdominal access during laparoscopic surgery. The clearance paves the way for Freyja Healthcare to introduce VereSee into the rapidly expanding women's health market, promising to bring about a new era of innovation in a field that has remained static for over thirty years.

Established by Jón Ívar Einarsson, MD, PhD, MPH, and Gaby Moawad, MD, FACOG, Freyja Healthcare is on a mission to enhance the standard of care in women's health through both surgical and in-office procedures. The VereSee device stands out with its unique design that prioritizes simplicity for surgeons and safety for patients, setting it apart from existing care standards. With four products nearing the end of their development phase, alongside 17 granted patents and 21 pending ones, Freyja is at the forefront of innovation in gynecologic solutions.

Kim Rodriguez, Freyja's Executive Chairman and former CEO of Acessa Health, expressed her admiration for Freyja's commitment to advancing gynecologic care for women and healthcare providers. In the United States alone, approximately 4.8 million laparoscopic surgeries are performed annually. The initial step of abdominal entry is notably the most hazardous across all laparoscopic surgeries, resulting in daily injuries and fatalities.

Jón Ívar Einarsson, MD, highlighted the risks associated with traditional entry methods like Veres needles or optical trocars, which can cause severe injuries or even death due to blind entry. Freyja's extensive testing and documentation during the FDA clearance process have validated the safety and efficacy of the VereSee device.

Gaby Moawad, MD, emphasized the rigorous journey towards FDA clearance but acknowledged its necessity in ensuring new products meet the highest safety and quality standards. With this achievement behind them, Freyja is gearing up for the initial commercialization phase of VereSee, anticipating widespread availability by the second half of 2024.

Freyja Healthcare was founded in 2017 by two highly esteemed minimally invasive gynecologic surgeons with a vision to improve surgical and in-office solutions for women's health. Drs. Einarsson and Moawad have leveraged their extensive experience to develop products that address unmet needs within their field. To date, Freyja has secured almost $8 million in seed funding from both private and professional investors.

With its innovative approach and dedication to enhancing women's healthcare, Freyja Healthcare is set to make significant contributions to the field of gynecology. The FDA clearance of VereSee marks just the beginning of what promises to be a transformative journey towards safer and more effective care for women worldwide.