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BioWorld - Friday, February 6, 2026
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Home » FDA green lights Ezra's Prostate AI and Plexo system
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FDA green lights Ezra's Prostate AI and Plexo system

Oct. 20, 2020
By Annette Boyle
The U.S. FDA cleared Ezra AI Inc.'s artificial intelligence (AI) system for prostate cancer and its cloud-based picture archiving and communication system (PACS) that enables radiologists to use the Prostate AI from their browser. The New York-based company’s Prostate AI is the first prostate-focused artificial intelligence system to gain clearance. The Prostate AI accurately quantifies prostate volume, lesion size, and renders 3D volumes of the prostate gland and lesions.
Medical technology Regulatory Diagnostics Artificial intelligence Digital health Cancer 510(k) FDA

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