Monogram Technologies Updates on 510(k) Submission After FDA Meeting

Monogram Technologies Inc., an AI-driven robotics company, provided an update on its recent meeting with the FDA regarding the 510(k) submission for their mBôs TKA System. Submitted in July 2024, the application passed the initial review but was put on hold pending a complete response to the Additional Information Request (AIR) received in September.

After written responses and a Submission Issue Request meeting on December 17, 2024, Monogram believes it has sufficiently addressed the FDA's concerns without the need for clinical data. A comprehensive response to the AIR is anticipated in Q1 2025. Attaining clearance would be significant for advancing orthopedic medicine standards.

The company is also pursuing regulatory clearance for clinical trials in India, aiming to begin trial training by January 2025. CEO Ben Sexson emphasizes the strategic importance of the developments and the multigenerational product strategy.