Freyja Healthcare Secures FDA 510(k) Clearance for VereSee™ Mini Laparoscope with VisualEntry™ System

Freyja Healthcare, LLC announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for VereSee™, the company's second-generation Mini Laparoscope with VisualEntry™ System. This clearance marks a significant milestone for the company as it aims 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 visualize anatomy during the entry process. Traditionally, laparoscopic entry is performed without direct visualization, relying on blind techniques that carry inherent risks. VereSee addresses this by providing real-time imaging from the moment of entry, potentially improving safety and precision.

“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 is designed with single-use entry components and reusable visualization technology, offering a practical healthcare economic model. It is classified as a Class II Endoscope and Accessories device under the 510(k) pathway.

Jon I. Einarsson, MD, founder of Freyja Healthcare, commented, “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.”

The implications of this clearance are substantial. By enabling visualization during entry, VereSee could reduce complications associated with blind entry, such as vascular or bowel injuries. Additionally, its miniature size may allow surgeons to perform certain procedures with fewer incisions, potentially leading to less postoperative pain and faster recovery for patients. The technology also aligns with the growing trend toward minimally invasive approaches and outpatient surgery, as it can be used in hospitals and ambulatory surgical centers.

With FDA clearance achieved, Freyja Healthcare will begin commercial introduction of VereSee, expanding access to this innovative technology among healthcare providers. This development underscores the ongoing evolution of laparoscopic surgery, where enhanced visualization and miniaturization are key drivers of improved patient outcomes and procedural efficiency.