EndoQuest Robotics announces that the company’s Flexible Robotic System has been accepted into the U.S. FDA’s Safer Technologies Program (STeP).
The FDA’s Safer Technologies Program is designed for devices expected to substantially enhance the safety of existing treatment options. Being part of this program means the Flexible Robotic System will benefit from a streamlined development and review process, ensuring expedited access for patients without compromising the rigorous safety and efficacy standards for FDA approval.
EndoQuest Robotics focuses on improving gastrointestinal and endoluminal surgeries through an advanced robotic system. Their technology allows for minimally invasive procedures, enhancing healthcare professionals’ capabilities. The company has collaborated extensively and will continue to do so with healthcare providers, researchers, and industry partners to advance the adoption of its flexible endoluminal robotic system, ultimately improving patient outcomes and redefining a new standard of care in minimally invasive surgery.
The FDA describes the Safer Technologies Program as a collaborative program intended to help reduce the time it takes to develop and obtain marketing authorization for eligible devices. It offers manufacturers an opportunity to interact with the FDA’s experts through several different program options to efficiently address topics as they arise during the premarket review phase, which can help manufacturers receive feedback from the FDA in a timely way.
“We are tremendously gratified by FDA’s decision to include our Flexible Robotic System in the Safer Technologies Program,” says Kurt Azarbarzin, CEO of EndoQuest Robotics. “We believe that our unique robotic platform will enhance physician control, precision, and efficiency, enabling safer and more effective minimally invasive treatments. We look forward to working with the FDA to bring the Flexible Robotic System to market and provide physicians and patients a new, scar-free approach for a wide variety of medical conditions and procedures.”
