Freyja Healthcare, LLC announced today that the U.S. Food and Drug Administration has granted 510(k) clearance for VereSee™, its second-generation Mini Laparoscope with VisualEntry™ System. The clearance marks a significant milestone for the company, which aims to improve visualization at the earliest stages of minimally invasive surgery.
VereSee is designed to bring visualization directly to laparoscopic entry, combining a miniature 2mm laparoscope with Freyja's VisualEntry System. This allows surgeons to see anatomy during the entry process, a departure from conventional techniques where initial abdominal access may occur without direct visualization. According to the company, the system enables surgeons to visualize the entry process, potentially reducing the risk of complications and improving patient outcomes.
"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 device is classified as a Class II Endoscope and Accessories device and was reviewed under the 510(k) premarket notification pathway. The system pairs single-use entry components with reusable visualization technology, aiming to fit naturally into the laparoscopic workflow while supporting a practical economic model for healthcare providers.
Jon I. Einarsson, MD, founder of Freyja Healthcare, emphasized the broader 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."
The implications of this clearance are significant for the medical device industry and for patients. By providing visualization during the entry phase, VereSee could reduce the risk of blind entry complications such as vascular or bowel injuries, which are rare but serious. Additionally, the ability to use the same miniature laparoscope for the entire procedure may eliminate the need for additional incisions, potentially reducing pain, scarring, and recovery time for patients. For healthcare systems, the reusable components could offer cost savings over time.
With FDA clearance achieved, Freyja Healthcare will begin commercial introduction of VereSee and expand access to hospitals, ambulatory surgical centers, and surgeons performing minimally invasive procedures. The company, focused on developing innovative solutions for minimally invasive surgery and women's health, continues to address unmet needs for physicians, healthcare systems, and patients.
