Titan Medical (TSX:TMD, NASDAQ:TMDI) has announced the human factors evaluation needed to support its planned Investigational Device Exemption filing with the US Food and Drug Administration has completed.
As quoted in the press release:
Commenting on the HFE, Arnold Advincula, M.D., Vice-Chair of Women’s Health & Chief of Gynecology at the Sloane Hospital for Women, Columbia University Medical Center/New York Presbyterian Hospital, and the Company’s Medical Advisor on Clinical Education and Hospital Economics, said, “It was exciting to see the latest improvements with the system during my recent participation in the summative human factors studies. For any novel surgical approach to gain a strong foothold in gynecology and other surgical specialties, the system must be user-friendly without compromising technical efficacy and surgical experience.
“During the summative studies, the procedural workflow that highlighted a simple yet sophisticated design approach of the system without reinventing the wheel, was easy to learn for myself and my surgical team. The streamlined design of the system made surgical assisting seamless and safe,” he added. “I was particularly impressed with innovative features like a dual-view camera system consisting of a flexible 3D high-definition camera along with an integrated 2D high-definition camera, and insightful overlays providing valuable spatial information for the multi-articulating instruments. These features are vital for simplifying single-port robotic surgery for the surgical community predominantly familiar with multi-port approaches. I remain enthusiastic with all the progress I am seeing toward making single-incision robotic surgery a reality that will become a standard part of our minimal access surgical armamentarium.”