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…