Aidoc gets FDA breakthrough status for radiology report drafting tool

Aidoc said the U.S. Food and Drug Administration granted Breakthrough Device Designation to First Read, an AI tool designed to analyze chest radiographs and generate preliminary radiology report text. The company said the system is intended to ease reporting and interpretation workloads as imaging demand outpaces capacity, with outpatient imaging interpretation turnaround times more than doubled between 2014 and 2023.

First Read builds on Aidoc’s CARE™ foundation model and broader clinical AI platform, which supports care decisions across nearly 2,000 hospitals worldwide and has analyzed more than 120 million patient cases to date. Aidoc said the tool uses the same underlying architecture as Triage, its FDA-cleared abdominal CT triage application, extending that foundation into report drafting workflows.

The designation is Aidoc’s second Breakthrough Device Designation in under a year, following CARE Triage in September 2025. Aidoc said First Read remains for investigational use only and has not been cleared or approved by the FDA; the designation Q260882 covers four life-threatening findings for broad chest radiograph analysis.