Freyja Healthcare is revolutionizing the women’s health market with its groundbreaking VereSee device, the first and only 2mm abdominal-access video-entry device for laparoscopic surgery. Recently, the device received 510(k) clearance from the United States Food and Drug Administration (FDA), marking a significant milestone in the company’s mission to bring innovation to women’s healthcare.
With four products in advanced stages of development, 17 granted patents, and 21 pending patents, Freyja Healthcare is focused on raising the standards of women’s health in both surgical and in-office procedures. The VereSee device, designed by founders Jón Ívar Einarsson, MD, PhD, MPH, and Gaby Moawad, MD, FACOG, offers a proprietary design that prioritizes simplicity for surgeons, safety for patients, and differentiation from current standards of care.
Currently, laparoscopic surgeries have a dangerous step during abdominal entry, resulting in one patient death and eight injuries each day in the United States alone. The standard practice of blind entry using Veres needles or a 5-12mm optical trocar has proven to be outdated and risky, often leading to significant harm or even death if undetected.
Freyja Healthcare’s VereSee device aims to change this by providing a safer and more effective solution. The extensive testing and documentation conducted during the FDA clearance process validate the company’s confidence in the product’s design and efficacy.
“FDA clearance has been a long process for us, but we understand the importance of upholding the highest safety and quality standards for these devices,” said Gaby Moawad, MD, co-founder and Board Director of Freyja Healthcare. “We are proud of the work our team has done to reach this significant milestone.”
In the second half of 2024, the VereSee device will be commercially available, providing surgeons with a groundbreaking tool that will enhance patient safety and improve outcomes. Freyja Healthcare continues to innovate and redefine the field of women’s health, striving to provide safe and effective surgical and in-office solutions for women around the world.
For more information about Freyja Healthcare and their mission to elevate women’s health standards, please visit their website.
Freyja Healthcare’s introduction of the VereSee device, the first and only 2mm abdominal-access video-entry device for laparoscopic surgery, is a revolutionary step in the women’s health market. The device recently received 510(k) clearance from the FDA, highlighting the company’s commitment to bringing innovation to women’s healthcare. With several products in development and a significant number of granted and pending patents, Freyja Healthcare is dedicated to raising the standards of women’s health in surgical and in-office procedures.
One key advantage of the VereSee device is its proprietary design, which prioritizes simplicity for surgeons, safety for patients, and differentiation from current standards of care. The device aims to address the dangerous step of abdominal entry in laparoscopic surgeries, which currently leads to one patient death and eight injuries each day in the United States. The standard practice of blind entry using Veres needles or a 5-12mm optical trocar has proven to be outdated and risky, often resulting in significant harm or even death if undetected.
By providing a safer and more effective solution, Freyja Healthcare’s VereSee device aims to reduce the risks associated with abdominal entry in laparoscopic surgeries. Extensive testing and documentation conducted during the FDA clearance process validate the company’s confidence in the product’s design and efficacy.
The availability of the VereSee device for commercial use is projected for the second half of 2024. This groundbreaking tool will enhance patient safety and improve surgical outcomes for laparoscopic procedures. Freyja Healthcare remains committed to innovation and redefining the field of women’s health, with the goal of providing safe and effective surgical and in-office solutions for women worldwide.
Some key challenges associated with the subject include the need for widespread adoption of the VereSee device by surgeons and healthcare facilities. Educating medical professionals about the benefits and safety of the device will be crucial for its successful integration into current medical practices.
Additionally, controversy may arise from discussions regarding the cost-effectiveness of the VereSee device compared to existing standard procedures. Economic considerations and reimbursement policies may impact the rate of adoption and utilization of the device within healthcare systems.
For more information about Freyja Healthcare and their mission to elevate women’s health standards, please visit their website: Freyja Healthcare.