Titan Medical Now Set to File 510(k) Submission in 2020

Titan Medical is delaying filing for FDA clearance of its single-port robotic surgical system until the first half of 2020. Previously, the Toronto-based company said it would file its 510 (k) by the end of the year. The Sport system is comprised of a surgeon-controlled patient cart that includes a 3-D high-definition vision system and multi-articulating instruments for performing minimally invasive surgeries, procedures, and a surgeon workstation that provides an advanced ergonomic interface to the patient cart and a 3-D endoscopic view inside the patient’s body. Titan Medical also announced the human factors evaluation (HFE) required to support its planned IDE filing with FDA was completed successfully and received a highly favorable assessment from the surgeon investigators. In a release, David McNally, Titan’s CEO said, “We have now successfully completed all [Good Laboratory Practice Regulations] and HFE studies, which have further demonstrated our single-port system’s best-in-class potential. Having achieved the expected results, we are compiling the associated reports from independent experts in preparation for our IDE submission with the FDA to begin human studies. In addition, we have engaged a top contract research organization to manage our human studies.” McNally added, “We will now take additional time to perfect our system and implement all planned system ...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news