Aidoc’s First Read X-Ray Reporting Software Gets FDA’s Breakthrough Device Designation

The Food and Drug Administration (FDA) has issued a Breakthrough Device Designation for First Read, an AI-powered software, which may facilitate enhanced efficiency in radiology reporting for X-ray interpretation.

Aidoc, the developer of First Read, said the software offers high-quality drafts for radiology reports based on AI evaluation of chest X-rays.

Acknowledging the challenges with errors and automation bias that can occur with the use of generative AI in radiology reporting, Aidoc maintained that the First Read software provides AI-assisted support while preserving quality standards and radiologist oversight for final approval of the report.

"Radiology is entering a new era," said Elad Walach, CEO and co-founder of Aidoc. "For decades, radiologists have carried growing workloads with tools that were never designed for today's scale of imaging demand. First Read represents an important step toward a future where safe, clinically validated AI can help absorb more of the operational burden, allowing radiologists to focus more of their time on interpretation, judgment, and patient care."