Freyja wins FDA approval for VereSee device

Freyja Healthcare, an early-stage medical device company, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its VereSee device for laparoscopic surgery.

Laparoscopic surgery is a minimally invasive surgical technique that involves making small incisions in the abdominal cavity through which specialized tools and a tiny camera are inserted. The camera allows the surgeon to view the inside of the body on a monitor, guiding him during the procedure.

The VereSee device is a 2 mm video-entry device with abdominal access intended for laparoscopic surgery in women. The device’s availability for commercial use is expected in the second half of 2024.

“Standards of care are unsafe and outdated,” said Freyja interim CEO Jón Ívar Einarsson.

“Initial insertion is often done blindly, using a 5-12 mm diameter Veres needle or optical trocar. Damage to the intestines or vascular system due to blind entry can cause significant harm and even death if undetected.”

Founded in 2017, Freyja has raised nearly $8 million in seed funding, including $1 million in a Series A funding round in April 2019. VereSee is the Boston-based company’s lead device, with four products in advanced stages of development.

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According to GlobalData’s analysis, the entire market for laparoscopic access tools will generate USD 299 million in 2030. The market is expected to grow due to the increase in surgical and minimally invasive procedures.

Innovations in the laparoscopic space include the development of robotic and magnetic surgery platforms. In August 2023, the FDA cleared Levita Magnetics’ MARS magnetic surgery platform, in which a magnet and machine provide surgeons with control over tissue manipulation with less scarring during laparoscopic procedures.

In July 2023, scientists from the École Polytechnique fédérale de Lausanne (EPFL) in Switzerland developed a four-arm laparoscopic system. It provides shared control between the surgeon and robotic assistants, with each hand operating the manipulation instrument while one foot operates the endoscope and the other foot operates the actuated gripper. The robotic system aims to reduce the surgeon’s workload and increase the precision and safety of surgery.