Freyja Healthcare, LLC announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for VereSee™, its second-generation Mini Laparoscope with VisualEntry™ System. This clearance marks a significant advancement in minimally invasive surgery, as VereSee is designed to bring visualization to the earliest stage of laparoscopic entry, a critical step that traditionally occurs without direct vision.
The device combines a miniature 2mm laparoscope with Freyja's VisualEntry™ System, allowing surgeons to visualize anatomy during the entry process. This novel approach could help reduce the risk of complications associated with blind entry, such as vascular or bowel injury. Moreover, once access is achieved, VereSee can serve as a standard laparoscope, potentially eliminating the need for an additional instrument in certain procedures.
“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 comprises single-use entry components and a reusable visualization core, offering a practical economic model for healthcare providers. It is classified as a Class II Endoscope and Accessories device under the 510(k) pathway, indicating it is substantially equivalent to existing devices.
Jon I. Einarsson, MD, founder of Freyja Healthcare, emphasized the broader impact: “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 clearance allows Freyja Healthcare to begin commercial introduction of VereSee, targeting hospitals, ambulatory surgical centers, and surgeons performing minimally invasive procedures. This innovation could improve patient safety and procedural efficiency, addressing a long-standing challenge in laparoscopic surgery.
Freyja Healthcare is a medical device technology company focused on developing solutions for minimally invasive surgery and women's health, with a mission to improve visualization, access, and efficiency. The company's technologies aim to meet unmet needs for physicians, healthcare systems, and patients.
