FDA OKs Freyja HealthCare’s Novel VereSee Device

Freyja HealthCare has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its novel VereSee device.
 
VereSee, according to the company, is the first and only 2 mm, safe abdominal-access video-entry device for laparoscopic surgery. Freyja hopes to bring more innovation in the women’s health market and reinvigorate a category that hasn’t seen innovation in over thirty years.
 
Boston, Mass.-based Freyja was founded by minimally invasive gynecological surgeons Jón Ívar Einarsson, MD, Ph.D., MPH, and Gaby Moawad, MD, FACOG. The company’s mission is to raise the standard of women’s health in surgical and in-office procedures.
 
VereSee is the company’s first novel product. It’s proprietary design was engineered to be simple for the surgeon, safe for patients, and differentiated from the current standard of care. The company currently has four products in advanced development stages, 17 granted patents, and 21 pending patents.
 
“The standard of care is dangerous and outdated. Initial entry is often done blindly with Veres needles or a 5-12mm optical trocar,” said Jón Ívar Einarsson, MD, co-founder and interim CEO of Freyja. “Damaging the bowel or vasculature because of blind entry can cause significant harm, even death, if undetected.”
 
“FDA clearance has been a long process for us, and we know that this is one of the largest barriers to entry for new products in this category,” added Gaby Moawad, MD, co-founder and Board Director of Freyja. “However, we understand the importance of these devices being held to the highest standards of safety and quality. We are proud of the work our team has done to reach this milestone for Freyja.”