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Monogram Technologies Provides Regulatory Update on mBôs TKA System and Clinical Trial Preparation in India

1. MGRM submitted its formal response to the FDA's additional information request. 2. Company completed supplemental testing for its mBôs TKA System.

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FAQ

Why Bullish?

Successful FDA submission can boost investor confidence, similar to other firms that gained after regulatory milestones.

How important is it?

The FDA process is crucial for MGRM's product viability, directly affecting its market position.

Why Short Term?

FDA approval could lead to immediate market reactions, influencing stock prices quickly.

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Company has Completed all Supplemental Testing and has Submitted its Formal Response to the FDA's Additional Information Request (AIR) Investigator Meeting and Clinical Trial Training Held at the Shalby Hospital in Ahmedabad, India AUSTIN, TX / ACCESS Newswire / February 26, 2025 / Monogram Technologies Inc. (NASDAQ:MGRM) ("Monogram" or the "Company"), an AI-driven robotics company focused on improving human health with an initial focus on orthopedic surgery, today provided an update regarding its 510(k) premarket filing submission to the U.S. Food and Drug Administration ("FDA") for the Company's mBôs TKA System. The Company has completed all supplemental testing and submitted its formal response to the U.S. Food and Drug Administration (FDA) regarding the Additional Information Request (AIR) received on September 30, 2024.

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