February 8, 2023
February 8, 2023

Ezra Announces First FDA-Cleared Prostate AI

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Ezra Announces First FDA-Cleared Prostate AI

The ezra team is excited to announce that we have received FDA 510(k) clearance for our ezra Prostate AI — the first ever prostate segmentation AI to be cleared by the FDA.

As a result of implementing this new AI technology, we are decreasing the price of the ezra Prostate Scan by 15%: from $675 to $575.

An AI such as ezra’s is particularly important for prostate MRIs. About half of the interpretation time for a prostate MRI consists of radiologists performing simple tasks that can be automated through the use of AI—including measuring the volume of the prostate gland, the size of a lesion, or segmenting the gland or lesion.

By using AI technology, radiologists’ workflow efficiency could be improved, thereby decreasing costs.

The ezra AI achieves three important goals, enabling a step forward in MRI-based prostate cancer screening, the highest incidence cancer in men:

  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.
prostate AI scan
AI-based prostate & lesion segmentation with 3D rendering

More FDA News: Clearance for Plexo To Speed Up Workflow Integration

Ezra has also created and received FDA clearance for Plexo, our cloud-based PACS (Picture Archiving and Communications System).

It works directly in the browser, and seamlessly integrates our Prostate AI into radiology workflows. This enables radiologists to use the Ezra platform without the need to install any software.

Ezra Is Making Prostate MRI Screening More Affordable

In 2020, 191,930 new cases of prostate cancer will be diagnosed in the US, and 33,330 men will die from the disease.

Despite the high incidence of prostate cancer in men, there is still no accurate screening test. The current standard of care—a prostate-specific antigen (PSA) blood test— has such a high rate of overdiagnosis that no organization presently endorses routine prostate cancer screening for men at average risk. The world needs a better way to screen for prostate cancer.

Recent research shows that a prostate MRI detects more clinically significant prostate cancers than PSA alone, which, in turn, decreases the need for unnecessary biopsies.

The challenge with a prostate MRI, however, is that it is still an expensive tool—prices for a contrast-enhanced prostate MRI range from $750 in an outpatient imaging facility up to $4,000 when done in a hospital.

The ezra team has worked tirelessly to make prostate MRIs more affordable. Our first step was the development and January 2019 launch of the ezra prostate cancer screening service, a fast, 20-minute non-contrast prostate cancer screening MRI.

We are proud to say that, to date, almost 1,000 men have been scanned with the ezra Prostate Scan.

Though a medical success, at a price tag of $675, our screening Prostate MRI Scan was not as affordable as we’d like it to be. Therefore, our next step was to create an AI to make the interpretation of our prostate MRI scans faster—thus bringing down the cost. With the FDA clearance of our Prostate AI, we’re now able to lower this fee to $575.

Even though our FDA clearance and price reductions are great steps in the right direction, there’s still a long way to go. 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.  

You can learn more about Ezra’s prostate AI on our Prostate AI page or by dropping me an email. Also – we’re hiring!

Stay healthy,

Emi Gal
CEO & co-founder