FDA 510(k) Clearance Already Has This Micro Cap Off To The Races

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Monday, March 17, 2025

A New York-based healthcare company is already turning heads during Monday’s premarket hours after it was announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Monogram mBos TKA System, according to a release from this morning. 

According to that same press release, this determination means that this company may market the devise, subject to the general controls provisions of the Act.

Traders wasted no time buying up shares of Monogram Technologies Inc. (Nasdaq:MGRM), with the current bid at the time of writing sitting at $2.57/share (10.30% implied open for sellers). It should be an exciting session for this micro cap!

Monogram Technologies Inc., formerly Monogram Orthopaedics Inc., is an artificial intelligence (AI)-driven robotics company focused on improving human health, with an initial focus on orthopedic surgery. The Company is developing a product solution architecture to enable patient-optimized orthopedic implants at scale by combining three-dimensional (3D) printing, advanced machine vision, AI and robotics. Its mBos precision robotic surgical system is designed to autonomously execute optimized paths for high-precision insertion of its mPress press-fit implants. The Company intends to produce and market robotic surgical equipment and related software, orthopedic implants, tissue ablation tools, navigation consumables, and other miscellaneous instrumentation necessary for reconstructive joint replacement procedures. The Company is also exploring other clinical and commercial applications for the mBos with mVision navigation.

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