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. This clearance marks a significant advancement in minimally invasive surgery, as VereSee is designed to bring direct visualization to the critical step of laparoscopic entry.
Traditional laparoscopic procedures often involve gaining access to the abdominal cavity without direct visualization, relying on blind techniques that carry inherent risks. VereSee aims to change this by combining a miniature 2mm laparoscope with Freyja's VisualEntry™ System, enabling surgeons to see anatomy during the entry process. According to the company, this approach allows for visualization at the very beginning of the procedure, potentially avoiding the need for an additional laparoscope in certain cases.
“FDA clearance of VereSee is an incredibly important milestone for Freyja Healthcare,” said Mike MacKinnon, CEO. “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 paired with reusable visualization technology, designed to integrate seamlessly into existing surgical workflows while supporting a practical economic model for healthcare facilities. The FDA reviewed VereSee under the 510(k) premarket notification pathway, classifying it as a Class II Endoscope and Accessories device.
Jon I. Einarsson, MD, founder of Freyja Healthcare, emphasized 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 initiate commercial introduction of VereSee, expanding access to hospitals, ambulatory surgical centers, and surgeons performing minimally invasive procedures. The company, focused on medical device innovation for minimally invasive surgery and women's health, continues to address unmet needs for physicians, healthcare systems, and patients.
For more information on this development, visit Freyja Healthcare.
