510k

Zacks Small Cap Research – MGRM: Monogram Receives Clearance from the FDA on its 510(k) Submission for its mBôs TKA System. – Go Health Pro

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By Thomas Kerr, CFA NASDAQ:MGRM READ THE FULL MGRM RESEARCH REPORT On March 17, 2025, Monogram (NASDAQ:MGRM) announced that the FDA has granted 510(k) clearance for its Monogram mBôs TKA System. This determination means that the company can move forward with upgrades and begin the commercialization process. The mBôs TKA System is designed to deliver … Read more

Zacks Small Cap Research – MGRM: Monogram Announces it has Received an Additional Information Request (AIR) from the FDA Regarding its Recent 510(k) Submission. – Go Health Pro

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By Thomas Kerr, CFA NASDAQ:MGRM READ THE FULL MGRM RESEARCH REPORT FDA Response to 510(k) Filing On October 6, 2024, Monogram (NASDAQ:MGRM) announced it had received an Additional Information Request (“AIR”) from the U.S. Food and Drug Administration (“FDA”) on September 30, 2024, regarding its 510(k) premarket filing submission for the semi-active mBôs TKA System. … Read more

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