Monogram Provides Regulatory Update Following Meeting with FDA [Yahoo! Finance]
Monogram Technologies Inc. (MGRM)
Company Research
Source: Yahoo! Finance
AUSTIN, TX / ACCESSWIRE / May 1, 2024 / Monogram Orthopaedics 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 related to the regulatory and commercialization path for its mBôs surgical system following its meeting with the U.S. Food and Drug Administration (the "FDA"). On April 19, 2024, Monogram received written feedback from the FDA regarding the Company's Q1 2023 pre-submission request. Subsequently, Monogram conducted a teleconference meeting with the FDA on April 24, 2024, to discuss the written feedback further and obtain feedback on the Monogram mBôs™ TKA System verification test plan, including a proposed clinical trial protocol on an outside the U.S. (OUS) target population. Management believes the feedback was comprehensive and will be advantageous for preparing a successful 510(k) submission to obtain clearance. The Company shared with
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MGRM
News
- Monogram Orthopaedics Completes Corporate Name Change to Monogram Technologies [Yahoo! Finance]Yahoo! Finance
- Monogram Orthopaedics Completes Corporate Name Change to Monogram TechnologiesAccesswire
- Monogram Orthopaedics Reports First Quarter 2024 Financial Results [Yahoo! Finance]Yahoo! Finance
- Monogram Orthopaedics Reports First Quarter 2024 Financial ResultsAccesswire
- Monogram Engages Contract Research Organization to Oversee mBôs Robot Clinical Trial Activities Outside the U.S. [Yahoo! Finance]Yahoo! Finance
MGRM
Sec Filings
- 5/17/24 - Form 424B3
- 5/15/24 - Form 8-K
- 5/14/24 - Form 8-K
- MGRM's page on the SEC website