Ezra wins expanded FDA 510(k) clearance for its Ezra Flash AI, now covering abdomen and pelvis MRI as well as the brain

Function Health/Ezra Full Body MRI

Ezra received a new FDA 510(k) clearance for Ezra Flash, its AI model that reduces noise in MRI images while keeping diagnostic detail. The clearance extends the tool from brain scans, cleared in June 2023, to abdomen and pelvis, which lets Ezra apply it across a full-body scan. Cleaner images from shorter scans are how the company plans to make screening faster and cheaper.

• Ezra Flash is an AI model that denoises MRI images while keeping diagnostic detail.
• Earlier 510(k) clearance (June 2023) covered neuro MRI only; this adds abdomen and pelvis.
• Founder and CEO Emi Gal set a goal of a 15-minute, $500 full-body MRI in 2026.
• Ezra says about 6% of scanned members have had a potential cancer found (company figure).