The US Food and Drug Administration (FDA) has granted breakthrough device designation to Aidoc’s First Read, an AI system that produces preliminary radiology report text based on chest radiograph analysis.
The company’s announcement follows an ongoing increase in imaging demand and growing concerns about interpretation delays within health systems.
First Read aims to help address interpretation bottlenecks in radiology departments by producing preliminary, high-quality drafts of radiology reports, potentially reducing the time required for reporting and interpretation by clinicians.
It is based on the same technical foundation as Aidoc’s previously FDA-cleared abdominal computed tomography (CT) triage application, Triage, and is designed to allow radiologists to spend more time on clinical judgment and patient care.
This clinical AI platform is used in nearly 2,000 hospitals worldwide, including Sutter Health, Wellspan Health, and Mercy, and has analysed more than 120 million patient cases.
The designation is intended for technologies that could significantly improve the diagnosis of serious conditions and meet an unmet clinical need, potentially accelerating patient access.
First Read is the second Aidoc technology to receive this designation in less than a year; CARE Triage was awarded the status in September 2025.
Aidoc’s enterprise platform, aiOS, is designed to integrate clinical AI into existing imaging and electronic medical record workflows at scale.
Aidoc CEO and co-founder Elad Walach said: “Radiology is entering a new era. 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.”
Aidoc recently secured $150m in Series E financing and continues to expand deployment of its clinical AI platform.
In September 2024, Aidoc announced the CE marking of four new AI algorithms on its aiOS platform for healthcare providers in Europe.
