Freyja Healthcare, LLC announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for VereSee™, the company's second-generation Mini Laparoscope with VisualEntry™ System. This clearance marks a significant milestone for the medical device company, which aims to enhance visualization at the earliest stages of minimally invasive surgery.
VereSee is designed to combine a miniature 2mm laparoscope with Freyja's VisualEntry™ System, allowing surgeons to visualize anatomy during the entry process. Traditionally, initial abdominal access in laparoscopic procedures is performed without direct visualization, but VereSee introduces a new approach by providing sight during entry. According to Mike MacKinnon, CEO of Freyja Healthcare, "We believe surgeons should have the ability to see when it matters most. VereSee brings visualization to the very beginning of the procedure while also providing the functionality of a miniature laparoscope, which may enable surgeons to avoid opening an additional laparoscope for certain procedures."
The system pairs single-use entry components with reusable visualization technology, creating a platform that integrates into existing surgical workflows while supporting a practical healthcare economic model. Once access is achieved, VereSee can continue to be used as a miniature laparoscope, potentially eliminating the need for a separate scope in some cases.
FDA reviewed VereSee under the 510(k) premarket notification pathway and classified it as a Class II Endoscope and Accessories device. Jon I. Einarsson, MD, founder of Freyja Healthcare, emphasized the broader implications: "VereSee represents more than a new method of laparoscopic entry. It is a miniature laparoscopic visualization platform that gives surgeons the opportunity to see anatomy from the moment of entry. We believe that has the potential to fundamentally change how surgeons think about access, while continuing to advance the miniaturization of laparoscopic visualization and scope functionality."
With this clearance, Freyja Healthcare will begin commercial introduction of VereSee and expand access to hospitals, ambulatory surgical centers, and surgeons performing minimally invasive procedures. The company focuses on developing innovative solutions for minimally invasive surgery and women's health, aiming to improve visualization, access, and procedural efficiency.
