FDA/Panel Decisions

ClearPoint Neuro Announces FDA Clearance For SmartFrame OR Stereotactic System

ClearPoint Neuro, Inc. (CLPT) announced it has received 510(k) clearance for SmartFrame OR Stereotactic System. Enhanced with the latest OR imaging technology, SmartFrame OR offers surgeons flexible workflows, including iCT forward projection, enabling precise image-based corrections to achieve submillimetric accuracy. The company plans to begin limited market release in the first half of 2024, with a planned full market release in the second half of 2024.

"Expanding ClearPoint's portfolio beyond the MRI into the operating room is of key strategic significance to the company in 2024 and beyond," said Joe Burnett, President and CEO at ClearPoint Neuro.

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