Ezra has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Ezra Flash AI model, which allows the company to improve imaging quality for MR images of the head, abdomen, and pelvis.
This new achievement builds on the company’s previous 510(k) clearance in June 2023 for its Ezra Flash software. Ezra added that the new clearance makes way for the company to speed up scan times for the Ezra Full Body Flash scan, noting that its goal is to launch a 15-minute, $500 full-body MRI scan by 2026.
Ezra Flash model improves image quality by reducing noise, boosts imaging for analysis by radiologists, and adheres to regulatory standards, the company said.