US medical device start-up Ezra has secured the Food and Drug Administration (FDA) 510(k) clearance for its artificial intelligence (AI) intended to help radiologists in analysing and segmenting prostate MRI.
The use of AI technology reduces the time and cost of MRI-based prostate cancer screening.
Ezra’s AI technology is developed to offer precise prostate volume measurements. It also provides automatic lesion quantification and automatic 3D volume rendering.
It is the first AI to be cleared by the agency for prostate cancer screening.
The company has also obtained FDA clearance for cloud-based Picture Archiving and Communications System (PACS) called Plexo, which enables the integration of the Ezra Prostate AI into radiology workflows.
The system enables radiologists to leverage Ezra platform without installing any software.
Ezra CEO and co-founder Emi Gal said: “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 US.
“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.”
Ezra intends to roll out its new AI technology in its cancer screening service. The company said it is offering a 15% reduction in the cost of Ezran scan.
Last year, the company launched its MRI-based prostate cancer screening service and full-body MRI scan. Ezra offers its cancer screening services in New York, San Francisco, and Los Angeles.