Monogram Technologies Receives Additional Information Request From FDA On September 30, 2024, Regarding Its 510(K) Premarket Filing Submission For mBôs TKA System
Portfolio Pulse from Benzinga Newsdesk
Monogram Technologies has received an Additional Information Request (AIR) from the FDA regarding its 510(K) premarket filing for the mBôs TKA System. The company has 180 days to respond, or the application will be considered withdrawn. Monogram is also pursuing submissions with OUS clinical data.
October 02, 2024 | 10:04 pm
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Monogram Technologies' 510(K) application for the mBôs TKA System is on hold due to an FDA AIR. The company has 180 days to respond, impacting its regulatory timeline and potential market entry.
The FDA's request for additional information places Monogram's application on hold, delaying potential market entry and affecting investor sentiment negatively in the short term. The 180-day deadline adds pressure, and the parallel pursuit of OUS data indicates a strategic pivot to mitigate risks.
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