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 step forward in the company's mission to enhance visualization at the earliest stages of minimally invasive surgery, potentially addressing a critical gap in current surgical practices.
VereSee is designed to bring visualization directly to the moment of laparoscopic entry. By combining a miniature 2mm laparoscope with Freyja's VisualEntry™ System, the device enables surgeons to see anatomy during the entry process, a departure from traditional methods where initial abdominal access may occur without direct visualization. The system is intended to provide a new approach to one of the most fundamental and critical steps in laparoscopic surgery, potentially reducing the risk of complications associated with blind entry.
“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 offers a dual function: it provides visualization during entry, and once access is achieved, it can serve as a miniature laparoscope for the remainder of the procedure. This versatility could allow surgeons to perform certain procedures without needing to switch to a larger scope, potentially improving efficiency and reducing tissue trauma. The system pairs single-use entry components with reusable visualization technology, creating a platform designed to integrate seamlessly into existing laparoscopic workflows while supporting a practical economic model for healthcare facilities.
The FDA reviewed VereSee under the 510(k) premarket notification pathway and classified it as a Class II Endoscope and Accessories device. This clearance is based on substantial equivalence to existing devices, demonstrating that VereSee meets the necessary safety and effectiveness standards.
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.”
The importance of this clearance extends beyond the product itself. For surgeons, the ability to visualize during entry could enhance patient safety by reducing the risk of inadvertent injury to blood vessels or organs. For healthcare systems, the potential to avoid additional laparoscopic ports may lower procedural costs and shorten recovery times. For patients, the promise of less invasive surgery with improved visualization could translate into better outcomes and fewer complications.
With FDA clearance achieved, Freyja Healthcare will begin the commercial introduction of VereSee and expand access to the technology among 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.
