AI-powered MRI cancer-screening tool receives FDA clearance

MRI cancer-screening tool receives FDA clearance: ©Romaset - stock.adobe.com

Ezra, a health care AI startup focused on early cancer detection through full-body MRI screening, announced new 510(k) clearance by the U.S. Food and Drug Administration for its advanced Ezra Flash AI model. This approval builds on its previous 510(k) clearance recognized in June 2023 and enables Ezra to empower its partner imaging facilities with faster, lower-cost imaging.

The Ezra Flash, a Class II medical device, allows Ezra to enhance the quality of imaging not only for neuro MRI images but also for the abdomen and pelvis, expanding its applicability across the entire body. This advancement operates under Ezra's commitment to make cancer screening more accessible and affordable, and will enable the company to accelerate the scan time for its Ezra Full Body Flash scan.

"This FDA clearance marks another milestone in our journey towards making affordable and fast full-body MRIs a reality," said Emi Gal, founder and CEO of Ezra, in a statement. "Our goal is to launch a 15-minute, $500 full body MRI scan in 2026, and this new FDA clearance is an important step in that direction.”

Key advancements to Ezra Flash include:

• Image quality improvement: The latest FDA clearance improves image quality by reducing noise within the image while maintaining diagnostic integrity.
• Enhanced imaging for radiologist analysis: Ezra’s improved image quality allows for more precise analyses, boosting radiologists’ ability to provide clear and actionable insights to patients.
• Maintained regulatory standards: As with Ezra’s previous clearance, this FDA approval reassures that Ezra Flash meets rigorous health and safety standards, making it a trusted option for both radiologists and patients.

"The FDA clearance of Ezra Flash represents a significant advancement in making AI-powered cancer screening more accessible," said Daniel K. Sodickson, MD, PhD, chief scientific advisor at Ezra. "This technology enables faster, more accurate early cancer detection, ultimately giving patients and their doctors clearer insights for making informed healthcare decisions."

Ezra is the first company globally to leverage AI across all three key components of the cancer screening process: imaging, analysis and reporting. The Ezra Flash AI enables Ezra to enhance MR image quality, Ezra AI assists radiologists when interpreting MRI images (FDA-cleared for Prostate MRI images), and Ezra Reporter AI creates an easily digestible translation of radiology reports that assist medical professionals in communicating screening results to Ezra members. About 6% of scanned Ezra members have identified potential cancer.