The U.S. Food and Drug Administration (FDA) has cleared Ezra Prostate AI, an artificial intelligence (AI) program designed to increase the efficiency with which radiologists analyze images of the prostate in order to diagnose prostate cancer.

The program, which is expected to decrease the cost of prostate MRIs, is the first-ever prostate segmentation AI to be cleared by the FDA, Ezra announced in a press release.

Despite the commonality of prostate cancer, there aren’t reliable screening tests to detect the disease early, when treatments are generally more successful. The standard diagnosis approach involves measuring levels of the prostate-specific antigen (PSA) protein in the blood. But this method is very prone to false positives, so much so that it usually is not recommended for people with an average cancer risk.

Imaging the prostate using MRI can detect clinically significant prostate cancers more effectively than PSA testing alone, which would decrease the need for unnecessary biopsies. However, MRIs are expensive; at a hospital, an MRI can cost as much as $4,000.

Ezra previously developed a fast, 20-minute prostate cancer screening MRI, which the company launched in early 2019. To date, this MRI has been used to screen nearly 1,000 people.

Although successful in some regards, the Ezra Prostate Scan still carried a hefty price tag of $675. The newly-cleared AI program allows these scans to be interpreted more efficiently, which can bring costs down: Ezra now is lowering the price of a scan to $575.

Traditionally, once MRI imaging of the prostate is completed, an expert radiologist interprets the resultant images. About half of the time that experts spend on interpretation, however, is spent doing fairly simple tasks that easily could be automated — for example, measuring the size of the prostate.

The Ezra Prostate AI is able to accomplish some of these tasks on behalf of the radiologist. Specifically, the AI can measure the size of the prostate, and any identified lesions on the prostate, and it can automatically render these measurements into three-dimensional volumes.

Ezra also has created, and received FDA clearance for, Plexo, a cloud-based program that allows radiologists to use the Ezra platform without needing to install software.

“Even though our FDA clearance and price reductions are great steps in the right direction, there’s still a long way to go,” said Emi Gal, CEO and co-founder at Ezra. “We’d like our prostate scan to be even more affordable and potentially covered by insurance, so the entire Ezra team is hard at work to make that a reality.”