Monogram Technologies Submits FDA 510(k) Application For mBôs TKA System Clearance On July 19, 2024
Portfolio Pulse from Benzinga Newsdesk
Monogram Technologies Inc. (NASDAQ:MGRM) has submitted a 510(k) premarket filing to the FDA for its mBôs TKA System. The application, submitted on July 19, 2024, has passed the FDA Administrative Review and is now under substantive review. A decision is expected within 90 days, though the process may be paused if additional information is requested.
August 08, 2024 | 12:11 pm
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Monogram Technologies has submitted a 510(k) premarket filing to the FDA for its mBôs TKA System. The application has passed the FDA Administrative Review and is now under substantive review. A decision is expected within 90 days, though the process may be paused if additional information is requested.
The submission of the 510(k) filing and its passing of the FDA Administrative Review is a positive development for Monogram Technologies. If the FDA grants clearance, it could significantly boost the company's market position and stock price. However, the process may be paused if additional information is requested, which introduces some uncertainty.
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