Freyja Healthcare, LLC announced today that the U.S. Food and Drug Administration has granted 510(k) clearance for VereSee™, the company's second-generation Mini Laparoscope with VisualEntry™ System. This clearance marks a significant step in the company's mission to enhance visualization at the earliest stages of minimally invasive surgery.
VereSee combines a miniature 2mm laparoscope with Freyja's VisualEntry™ System, allowing surgeons to see anatomy during the entry process—a departure from conventional techniques where initial abdominal access is often performed without direct visualization. The device is designed to provide visualization from the moment of entry, potentially enabling surgeons to avoid the need for an additional laparoscope in certain procedures.
“FDA clearance of VereSee is an incredibly important milestone for Freyja Healthcare,” said 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, aiming to fit naturally into the laparoscopic workflow while supporting a practical economic model for healthcare providers. The 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 the commercial introduction of VereSee and expand access to the technology among 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, addressing unmet needs for physicians, healthcare systems, and patients.
