Freyja Healthcare Announces FDA 510(k) Clearance of VereSee™, Mini Laparoscope with VisualEntry™ System

FDA clearance marks a significant milestone for Freyja Healthcare and introduces a new approach to laparoscopic visualization and entry

FRAMINGHAM, MA, August 18, 2026 /24-7PressRelease/ -- Freyja Healthcare, LLC today announced 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 FDA clearance represents a major milestone for Freyja Healthcare and its mission to advance visualization at the earliest stages of minimally invasive surgery.

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.

"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."

Unlike conventional approaches in which initial abdominal access may occur without direct visualization, VereSee is designed around a simple concept: provide visualization during entry rather than waiting until after access has been established. Once access is achieved, VereSee may also give surgeons the option to continue using the same miniature laparoscope for visualization.

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.

VereSee was reviewed by FDA under the 510(k) premarket notification pathway and is classified as a Class II Endoscope and Accessories device.

"VereSee represents more than a new method of laparoscopic entry," said Jon I. Einarsson, MD, founder of Freyja Healthcare. "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 FDA clearance achieved, 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.

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.

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