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:
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.
For more coverage based on industry expert insights and research, subscribe to the Diagnostic Imaging e-Newsletter here.
Considering Breast- and Lesion-Level Assessments with Mammography AI: What New Research Reveals
June 27th 2025While there was a decline of AUC for mammography AI software from breast-level assessments to lesion-level evaluation, the authors of a new study, involving 1,200 women, found that AI offered over a seven percent higher AUC for lesion-level interpretation in comparison to unassisted expert readers.
Can CT-Based Deep Learning Bolster Prognostic Assessments of Ground-Glass Nodules?
June 19th 2025Emerging research shows that a multiple time-series deep learning model assessment of CT images provides 20 percent higher sensitivity than a delta radiomic model and 56 percent higher sensitivity than a clinical model for prognostic evaluation of ground-glass nodules.
FDA Clears Ultrasound AI Detection for Pleural Effusion and Consolidation
June 18th 2025The 14th FDA-cleared AI software embedded in the Exo Iris ultrasound device reportedly enables automated detection of key pulmonary findings that may facilitate detection of pneumonia and tuberculosis in seconds.