Freyja Healthcare, LLC announced today that the U.S. Food and Drug Administration has granted 510(k) clearance for VereSee™, its 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.
The VereSee device is designed to bring direct visualization to laparoscopic entry, combining a miniature 2mm laparoscope with Freyja's VisualEntry™ System. This innovation allows surgeons to see anatomy during the entry process, addressing one of the most critical steps in laparoscopic surgery. Traditionally, initial abdominal access is performed without direct visualization, but VereSee changes that paradigm by providing sight from the outset.
Mike MacKinnon, CEO of Freyja Healthcare, emphasized the importance of this clearance: "FDA clearance of VereSee is an incredibly important milestone for 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 designed to integrate seamlessly into existing laparoscopic workflows while supporting a practical healthcare economic model. Once access is achieved, surgeons can continue using the same miniature laparoscope for visualization, potentially reducing the need for additional instruments.
VereSee was reviewed under the FDA's 510(k) premarket notification pathway and is classified as a Class II Endoscope and Accessories device. Jon I. Einarsson, MD, founder of Freyja Healthcare, noted: "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, focused on medical device technology for minimally invasive surgery and women's health, aims to improve visualization, access, and procedural efficiency while addressing unmet needs for physicians, healthcare systems, and patients.
