I'm excited to share that Ezra has received new FDA 510(k) clearance for a new version of our Ezra Flash AI. This clearance significantly expands our ability to enhance MR image quality across the entire body, including the abdomen and pelvis, building upon our previous neuro imaging capabilities.
This milestone is particularly significant as it validates our AI technology's ability to maintain diagnostic integrity while enabling Ezra to reduce scan times – a crucial combination that will help make cancer screening more accessible and affordable. The enhanced Ezra Flash AI, classified as a Class II medical device, enables our partner imaging facilities to deliver higher quality images in less time.
Let me share the key technical advancements that this new FDA clearance brings:
First, our Ezra Flash AI now delivers improved image quality by effectively reducing noise while preserving crucial diagnostic information across neuro, abdomen, and pelvis. This enhancement is particularly important for complex anatomical areas like the abdomen and pelvis, where clear imaging is essential for accurate screening.
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Second, the improved image quality translates directly to more precise analyses by radiologists. By providing clearer images, we're enhancing our radiologists' ability to deliver accurate, actionable insights to patients.
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This new FDA clearance is also a crucial step toward our goal of launching a 15-minute, $500 full-body MRI scan in 2026. As Dr. Daniel K. Sodickson, our Chief Scientific Advisor, notes, "This technology enables faster, more accurate early cancer detection, ultimately giving patients and their doctors clearer insights for making informed healthcare decisions."
At Ezra, we're proud to be the first company globally to integrate AI across the entire cancer screening process – from imaging with Ezra Flash, to analysis with our FDA-cleared Ezra Prostate AI (for Prostate MRI images), to reporting through our Ezra Reporter AI. This comprehensive approach has already made a significant impact, with about 6% of our members identifying potential cancer through their Ezra scans.
As we continue serving patients across our 74 locations in 29 U.S. cities, this FDA clearance reinforces our commitment to maintaining the highest standards of safety and efficacy while advancing the field of cancer screening technology.
This is more than just a regulatory milestone – it's an important step forward towards our mission of making early cancer detection accessible to everyone. We remain committed to pushing the boundaries of medical imaging technology while maintaining the rigorous safety and quality standards that our members trust.
It is still Day 1.
In Health,
Emi Gal
Founder & CEO
