FDA grants Aidoc Breakthrough Device Designation for chest x-ray AI

Aidoc has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for First Read, an AI tool designed to analyze chest radiographs and generate preliminary radiology report text.

First Read is built on the same underlying architecture as Triage, Aidoc's FDA-cleared abdominal CT triage application, and is intended to reduce time spent on reporting while preserving radiologist oversight and final approval. The designation is Aidoc's second Breakthrough Device Designation in under a year, following Care Triage, which received the designation in September 2025.

The FDA grants Breakthrough Device Designation to technologies that significantly advance the diagnosis of severe diseases and represent an unmet clinical need, with the intent of accelerating access to such innovations. Aidoc's platform currently supports care decisions across nearly 2,000 hospitals worldwide and has analyzed more than 120 million patient cases, the company said.