Freyja Healthcare, LLC announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for VereSee™, its second-generation Mini Laparoscope with VisualEntry™ System. This clearance marks a significant step for the company in its mission to improve visualization during the earliest stages of minimally invasive surgery.
VereSee is designed to bring visualization directly to the point of laparoscopic entry, combining a miniature 2mm laparoscope with Freyja's VisualEntry System. By allowing surgeons to see anatomy during the entry process, VereSee introduces a novel approach to a critical step in laparoscopic procedures, which traditionally may be performed without direct visualization.
“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 system pairs single-use entry components with reusable visualization technology, creating a platform that fits into the existing laparoscopic workflow and supports a practical healthcare economic model. Once access is achieved, VereSee can continue to be used as a miniature laparoscope for visualization, potentially eliminating the need for a separate scope in some cases.
VereSee was reviewed under the FDA's 510(k) premarket notification pathway and is classified as a Class II Endoscope and Accessories device. This clearance is a key milestone for Freyja Healthcare as it prepares for commercial introduction of the device.
Jon I. Einarsson, MD, founder of Freyja Healthcare, commented, “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 begin commercializing VereSee, expanding access to hospitals, ambulatory surgical centers, and surgeons performing minimally invasive procedures. The company focuses on developing innovative solutions for minimally invasive surgery and women's health, aiming to improve visualization, access, and procedural efficiency.
The introduction of VereSee could have significant implications for the field of laparoscopic surgery. By enabling visualization during entry, it may enhance safety and precision, potentially reducing the risk of complications. Additionally, the ability to use the same miniature scope throughout the procedure could streamline workflows and reduce the need for multiple instruments, offering potential cost savings for healthcare systems.
As Freyja Healthcare moves forward with commercial launch, the medical community will be watching to see how this technology is adopted and whether it lives up to its potential to transform laparoscopic entry and visualization.
