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. This clearance represents a significant regulatory milestone for the company and brings a novel approach to laparoscopic surgery by allowing surgeons to visualize anatomy during the entry process.
VereSee combines a miniature 2mm laparoscope with the VisualEntry™ System, enabling surgeons to see directly during the critical step of establishing access into the abdominal cavity. Traditionally, initial access is performed without direct visualization, relying on blind techniques or tactile feedback. By integrating visualization into this phase, VereSee introduces a new standard that could reduce the risk of complications and improve procedural 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 designed to offer versatility: after entry, surgeons can continue using the same miniature laparoscope for visualization, potentially eliminating the need for a separate scope. This dual function could streamline surgical workflows and reduce costs by minimizing the number of instruments required per procedure.
The system comprises single-use entry components paired with reusable visualization technology, striking a balance between sterility and economic sustainability. This model is intended to integrate seamlessly into existing laparoscopic practices while supporting cost-effectiveness for healthcare providers.
VereSee was reviewed under the FDA’s 510(k) premarket notification pathway and is classified as a Class II endoscope and accessories device. The clearance underscores its safety and effectiveness for the intended use, paving the way for commercial distribution in the United States.
“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.”
With this clearance, Freyja Healthcare will initiate commercial introduction of VereSee, targeting 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 address unmet clinical needs and improve procedural efficiency.
The introduction of VereSee could have significant implications for patient safety and surgical practice. By enabling visualization during entry, it may reduce the risk of vascular or visceral injury, a rare but potentially devastating complication of laparoscopic access. Moreover, the miniaturization of visualization technology aligns with the broader trend toward less invasive procedures, potentially enabling earlier intervention and faster recovery.
As healthcare systems increasingly emphasize value-based care, technologies that enhance safety while controlling costs are likely to gain traction. VereSee’s dual-use design and reusable components may offer a compelling economic proposition, potentially justifying its adoption in various clinical settings.
Freyja Healthcare’s achievement also highlights the ongoing innovation in medical devices aimed at improving surgical outcomes. As the company expands access to VereSee, further clinical evidence may emerge to validate its benefits in real-world practice, shaping future guidelines for laparoscopic entry techniques.
