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Industry-First Prostate AI Cleared by FDA


Algorithm cleared to help radiologists analyze and segment prostate MRI.

New York-based start-up Ezra, a company focused on early cancer screening with MRI, has secured 510(k) clearance for its artificial intelligence (AI) tool for prostate cancer screening.

As the first prostate AI algorithm to receive clearance from the U.S. Food & Drug Administration, Ezra Prostate AI is designed to help radiologists analyze and segment prostate MRI while simultaneously reducing time and cost associated with MRI-based prostate cancer screening.

“Over the past two years, our team has worked tirelessly on building Ezra’s Prostate AI, and I’m thrilled to bring it to our imaging partners across the U.S.,” said Emi Gal, chief executive officer and co-founder of Ezra. “We will continue to work towards making the interpretation of prostate MRI scans faster and more affordable, in order to support the millions of men who are at risk of prostate cancer.”

Overall, company officials said, the prostate AI tool offers three capabilities:

  • Accurate prostate volume measurements
  • Automatic lesion quantification: This tool helps providers segment lesions and can display lesion size automatically.
  • Automatic 3D volume rendering: Via the segmentation capabilities, radiologists can automatically render prostate gland and lesions 3D volumes, improving workflow efficiency.

According to company representatives, Ezra Prostate AI requires no software installation – the Ezra Plexo, a cloud-based PACS, has also received FDA clearance, and works directly in a web browser.

Ezra launched its MRI-based prostate cancer screening service in January 2019 and its full-body MRI scan in May 2019. In response to this FDA clearance, the company is dropping the price of an Ezra scan by 15 percent to $575.

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