Freyja Healthcare, LLC has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its VereSee™ Mini Laparoscope with VisualEntry™ System. This clearance is a significant milestone for the company, which aims to enhance visualization at the earliest stages of minimally invasive surgery.
VereSee is a second-generation device that combines a miniature 2mm laparoscope with the VisualEntry™ System, allowing surgeons to visualize anatomy during the entry process. Traditionally, laparoscopic entry is performed without direct visualization, which can pose risks. By integrating visualization into this critical step, VereSee introduces a new paradigm in laparoscopic access.
Mike MacKinnon, CEO of Freyja Healthcare, emphasized the importance of this clearance: "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 is designed to fit naturally into existing surgical workflows, with single-use entry components and reusable visualization technology. This approach supports a practical healthcare economic model while maintaining high standards of care.
VereSee was reviewed under the FDA's 510(k) premarket notification pathway and is classified as a Class II Endoscope and Accessories device. This clearance underscores the device's safety and effectiveness for its intended use.
Jon I. Einarsson, MD, founder of Freyja Healthcare, highlighted 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, expanding access to hospitals, ambulatory surgical centers, and surgeons performing minimally invasive procedures. The company remains committed to developing innovative solutions that improve visualization, access, and procedural efficiency in minimally invasive surgery and women's health.
