New York-based startup Ezra announces that it has received U.S. FDA 510(k) clearance for its artificial intelligence (AI) product, which is designed to assist radiologists in analyzing and segmenting prostate MRI.

“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.,” says Emi Gal, CEO and co-founder of Ezra. “We will continue to work toward 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.” 

The Ezra AI facilitates: 

  1. Accurate prostate volume measurements. Accurate prostate volume is critical to screening because the size of the prostate is often an indication of potential disease. 
  2. Automatic lesion quantification. Under current processes, if a lesion is identified in the prostate, a radiologist has to manually measure the size of the lesion and grade it using the PI-RADS methodology. The Ezra Prostate AI helps radiologists segment lesions and can display the size of a lesion automatically, saving time and minimizing patient worry. 
  3. Automatic 3D volume rendering. Thanks to the Ezra Prostate AI’s segmentation capabilities, radiologists can automatically render 3D volumes of the prostate gland and lesions, which can improve their workflow efficiency.

To integrate the Ezra Prostate AI into radiology workflows, Ezra has also obtained FDA clearance for Plexo, a cloud-based PACS that works directly in the browser. This enables radiologists to use the Ezra platform without the need to install any software.

“Ezra is at the forefront of MRI-based cancer screening, and the company’s 510(k) FDA clearance for its Prostate AI is further validation of its innovation capabilities,” says Lawrence Tanenbaum, MD, FACR, vice president and CTO, director of MRI, CT, and advanced imaging at outpatient radiology provider RadNet.