Freyja Healthcare, LLC has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its VereSee™ Mini Laparoscope with VisualEntry™ System, the company announced today. This clearance marks a major milestone for the medical device company, as it introduces a novel approach to laparoscopic surgery that prioritizes visualization from the very start of the procedure.
The VereSee system is a second-generation mini laparoscope that integrates a 2mm scope with the VisualEntry™ System, designed to provide surgeons with direct visualization during the entry phase of laparoscopic surgery. Traditionally, surgeons have performed initial abdominal access without direct visualization, relying on tactile feedback and anatomical landmarks. VereSee changes this paradigm by allowing surgeons to see the anatomy as they gain access, potentially improving safety and precision during this critical step.
“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.”
Beyond the entry phase, VereSee can continue to serve as a visualization tool throughout the procedure, potentially eliminating the need for a separate laparoscope in some cases. This dual functionality could streamline workflows and reduce the number of devices required in the operating room, offering both clinical and economic benefits.
The system combines single-use entry components with reusable visualization technology, a design intended to fit seamlessly into existing laparoscopic workflows while supporting a sustainable healthcare economic model. The FDA reviewed VereSee under the 510(k) premarket notification pathway and classified it 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.”
The implications of this clearance are significant for the field of minimally invasive surgery. By enhancing visualization during entry, VereSee could reduce the risk of complications such as vascular or bowel injuries, which are rare but serious risks associated with laparoscopic access. Additionally, the potential to avoid using a larger laparoscope could lead to smaller incisions, less postoperative pain, and faster recovery times for patients.
For healthcare systems, the economic model of combining single-use components with reusable technology may offer cost efficiencies by reducing the need for multiple scopes per procedure. This could be particularly appealing to ambulatory surgical centers and hospitals looking to optimize resource utilization.
With FDA clearance achieved, Freyja Healthcare will now begin commercial introduction of VereSee, expanding access to hospitals, ambulatory surgical centers, and surgeons performing minimally invasive procedures. The company, based in Framingham, MA, focuses on developing innovative solutions for minimally invasive surgery and women's health, aiming to address meaningful unmet needs for physicians, healthcare systems, and patients.
