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 for the company in its mission to enhance visualization at the earliest stages of minimally invasive surgery.
VereSee combines a miniature 2mm laparoscope with the VisualEntry System, allowing surgeons to visualize anatomy during the entry process. Traditionally, laparoscopic entry is performed without direct visualization, but VereSee aims to change that by providing sight during the critical initial access. Once access is achieved, the same scope can be used for visualization, potentially avoiding the need for an additional laparoscope 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 device is designed as a platform that pairs single-use entry components with reusable visualization technology, aiming to fit seamlessly into the existing laparoscopic workflow while supporting a practical economic model for healthcare providers. The FDA reviewed VereSee under the 510(k) premarket notification pathway and classified 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.”
The clearance enables Freyja Healthcare to begin commercial introduction of VereSee, expanding access to hospitals, ambulatory surgical centers, and surgeons performing minimally invasive procedures. This development could influence surgical practices by offering a new tool that prioritizes visualization during a critical phase of surgery, potentially improving patient outcomes and procedural efficiency.
Freyja Healthcare, based in Framingham, MA, is dedicated to developing innovative solutions for minimally invasive surgery and women's health, focusing on improving visualization, access, and procedural efficiency to address unmet needs for physicians, healthcare systems, and patients.
