STeP, a collaborative program, helps reduce the time needed to develop and obtain marketing authorization for eligible devices. The FDA launched STeP in 2021, modeling the program on its breakthrough devices designation program. STeP covers devices that could improve the safety of treatments or diagnostics. They treat underlying diseases or conditions considered less serious than those treated or diagnosed by devices eligible for breakthrough designation.
According to EndoQuest, joining this program enables a streamlined development and review process. The company expects it to ensure expedited access without compromising the standards of FDA approval.
EndoQuest designed its surgical robot platform to address unmet needs in gastrointestinal and other endoluminal surgeries. It developed a system that offers precision and flexibility to improve patient outcomes. The proprietary technology navigates and performs procedures within the body’s lumina spaces, allowing for minimally invasive interventions.
The platform makes it possible for therapeutic endoscopists and surgeons to operate through a trans-oral or trans-anal approach. EndoQuest raised $42 million to support the platform last month.
“We believe that our unique robotic platform will enhance physician control, precision, and efficiency, enabling safer and more effective minimally invasive treatments,” said Kurt Azarbarzin, CEO of EndoQuest Robotics. “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.”