Core Viewpoint - ClearPoint Neuro, Inc. has received FDA's 510(k) clearance for its ClearPoint Navigation Software Version 3.0, which enhances surgical navigation capabilities in both MRI suites and operating rooms, potentially benefiting over 50 global biopharma partners and standardizing cell and gene therapy delivery in the U.S. [1][2] Company Developments - ClearPoint Navigation Software Version 3.0 introduces an intraoperative CT workflow, expanding its capabilities beyond MRI-guided workflows to include operating room applications [6][7] - The software is compatible with intraoperative CT and Conebeam CT imaging, broadening access to precision-guided neurosurgery for facilities lacking intraoperative MRI capabilities [7] - A limited market release for ClearPoint Navigation Version 3.0 is anticipated in Q1 2025, with a full market release planned for the second half of 2025 [8] Financial Performance - ClearPoint has a market capitalization of 17.99 in after-market trading [3] - Over the past year, CLPT's shares have risen by 135.1%, significantly outperforming the industry growth of 9% [13] Industry Prospects - The intraoperative CT market is projected to grow at a compound annual growth rate (CAGR) of 7.3% from 2024 to 2031, driven by demand for precise surgery, technological advancements, and an increase in chronic disorders [11]
CLPT Stock Gains on FDA Clearance for Navigation Software Version 3.0