New View Surgical’s VisionPort System Wins FDA Nod

New View Surgical Inc., a medical device company developing proprietary imaging and access technologies for minimally invasive surgery (MIS), received 510(k) clearance from the U.S. Food and Drug Administration for its VisionPort System. The VisionPort imaging and access system simplifies laparoscopic procedures for hospitals and provides surgeon-controlled visualization. Its dual-camera design offers multiple, simultaneous views of the anatomy and surgical instrumentation—unavailable with conventional laparoscopic systems. The VisionPort puts the most advanced visualization technology more readily in the hands of customers and is intended to be used in a broad range of diagnostic and therapeutic procedures within the thoracic and abdominal cavities. It is adaptable to a wide variety of surgical environments, representing a significant market opportunity.
 
“The VisionPort System allows the surgeon to control the scope and keeps the tip of the instruments within the field of view at all times. This has significant potential to make the operation easier for the surgeon and reduce risk to the patient,” commented David Earle, MD, FACS, Director of the New England Hernia Center and Associate Professor of Surgery at Tufts University School of Medicine in Boston, Mass. “Additionally, the VisionPort provides multiple, simultaneous views of the operative field. Previously, changing the viewing angle was only possible by removing the laparoscope and moving it to another port, frequently wasting time and causing frustration. Furthermore, the VisionPort eliminates a separate incision and the need for a surgical assistant to hold the scope. The elimination of the camera port and assistant means surgeons and hospitals can expand access to the operating room without increasing staffing requirements. This increased efficiency is good for the surgeon, the facility, and most importantly, the patient.”
 
Added Dr. Earle, “It’s been exciting to collaborate with the New View Surgical team during the development of the VisionPort. Not only will this technology allow more patients to access minimally invasive surgical techniques, it will also make many high volume procedures easier for surgeons to perform.”
 
“FDA clearance of the VisionPort is a significant milestone for New View Surgical. We’re excited to bring a revolutionary technology to market that supports our overall mission to improve the outcomes and efficiency of laparoscopic surgical procedures, all while increasing patient access to minimally invasive surgical techniques worldwide,” said Bryce Klontz, president and CEO. “The FDA clearance process for the VisionPort was completed in less than 90 days. We are incredibly pleased with the timeline as we can now move ahead with the next stages of company development and commercialize this exciting technology.”