Freyja Healthcare Secures FDA Clearance for VereSee Mini Laparoscope, Advancing Visualization in Minimally Invasive Surgery

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. The clearance marks a significant milestone for the Framingham, Massachusetts-based medical device company, which focuses on developing innovative solutions for minimally invasive surgery and women's health.

VereSee is designed to bring visualization directly to laparoscopic entry, combining the capabilities of a miniature 2mm laparoscope with Freyja's VisualEntry™ System. By enabling surgeons to visualize anatomy during the entry process, VereSee introduces a new approach to one of the most fundamental and critical steps in laparoscopic surgery. Traditionally, initial abdominal access may occur without direct visualization, but VereSee is built around a simple concept: provide visualization during entry rather than waiting until after access has been established.

“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, creating a platform designed to fit naturally within the laparoscopic surgical workflow while supporting a practical healthcare economic model. This design could offer cost efficiencies for hospitals and ambulatory surgical centers by potentially reducing the need for additional scopes and improving procedural efficiency.

VereSee was reviewed by FDA under the 510(k) premarket notification pathway and is classified as a Class II Endoscope and Accessories device. With clearance, Freyja Healthcare will begin commercial introduction of VereSee, expanding access to the technology among hospitals, ambulatory surgical centers, and surgeons performing minimally invasive procedures.

The implications of this clearance are substantial. For surgeons, VereSee offers the opportunity to see anatomy from the moment of entry, potentially reducing the risk of complications during laparoscopic access. For patients, enhanced visualization could lead to safer procedures and better outcomes. For the healthcare industry, this innovation represents a step forward in the miniaturization of laparoscopic visualization, which may pave the way for more minimally invasive techniques and improved recovery times.

Jon I. Einarsson, MD, founder of Freyja Healthcare, emphasized the transformative potential: “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.”

Freyja Healthcare is a medical device technology company focused on developing innovative solutions for minimally invasive surgery and women's health. The company develops technologies designed to improve visualization, access, and procedural efficiency while addressing meaningful unmet needs for physicians, healthcare systems, and patients. With this FDA clearance, the company is poised to make a significant impact on the field of laparoscopic surgery.