Aidoc Receives FDA Breakthrough Designation for AI Radiology Report Drafting

Aidoc has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its new AI tool called First Read, announced in a press release. The system analyzes chest radiographs and generates preliminary radiology report text to assist radiologists in managing rising imaging volumes.

First Read extends Aidoc's CARE foundation model into report drafting workflows. It is intended to reduce reporting time by producing high quality draft text from imaging findings, allowing radiologists to focus on interpretation and clinical decision making. The company states that the model builds on the same architecture as its FDA cleared abdominal CT triage application.

This is Aidoc’s second Breakthrough Device Designation within a year, following CARE Triage in September 2025. The designation is reserved for technologies that significantly advance diagnosis or treatment of serious conditions and address unmet clinical needs.

Aidoc’s platform, deployed across nearly 2,000 hospitals, integrates AI into imaging and electronic medical record systems through its aiOS operating system. The company reports that its technology has analyzed over 120 million patient cases worldwide.