Monogram Technologies Provides 510(k) Submission Update Following Positive Meeting with FDA
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Monogram Technologies Inc. (NASDAQ:MGRM) provided an update on its 510(k) submission for the mBôs TKA System following a positive meeting with the FDA. The company believes it has addressed the FDA's concerns, potentially avoiding the need for clinical data requests, and expects a comprehensive AIR response in Q1 2025.
December 18, 2024 | 1:45 pm
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Monogram Technologies has updated its 510(k) submission status for the mBôs TKA System after a positive FDA meeting. The company believes it has addressed FDA concerns, potentially avoiding further clinical data requests, with a comprehensive AIR response expected in Q1 2025.
The positive update from the FDA meeting suggests that Monogram Technologies is on track with its 510(k) submission, which is crucial for the approval of its mBôs TKA System. The anticipation of a comprehensive AIR response in Q1 2025 without the need for additional clinical data is a positive indicator for the company's regulatory progress, likely boosting investor confidence and potentially impacting the stock price positively in the short term.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100