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
FDA Center for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration/Wikipedia)
EndoQuest Robotics, Inc., (the “Company”) a privately-held medical device company and pioneering leader in the development of innovative endoluminal robotic technologies, announced today that the Company’s Flexible Robotic System has been accepted into the U.S. Food and Drug Administration’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 our product 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.
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,” said 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.”
EndoQuest Robotics is focused on addressing the unmet needs in gastrointestinal (“GI”) and other endoluminal surgeries by developing an innovative robotic system that offers precision, flexibility, and improved patient outcomes. The Company’s proprietary technology is designed to navigate and perform procedures within the body’s natural orifices, allowing for the least invasive interventions and enhancing the capabilities of healthcare professionals. Since EndoQuest Robotics was founded, the Company has collaborated extensively and will continue to do so with healthcare providers, researchers, and industry partners to advance the adoption of its revolutionary flexible endoluminal robotic system, ultimately improving patient outcomes and redefining a new standard of care in minimally invasive surgery.
Source: Company Press Release