Aidoc has received FDA Breakthrough Device Designation for First Read, an artificial intelligence tool designed to analyze chest X-rays and generate preliminary radiology report text, the New York-based company announced Thursday.

First Read is intended to assist radiologists by producing an initial report draft that clinicians review and approve, rather than replacing physician interpretation. The designation applies to software aimed at addressing an unmet clinical need and may provide an expedited pathway for FDA interactions during development and review.

Aidoc said the technology is designed to help address growing imaging volumes and radiologist workforce constraints. The company cited a recent study from the Neiman Health Policy Institute that found outpatient imaging interpretation turnaround times more than doubled between 2014 and 2023, with the largest increases occurring during the final two years of that period. According to the company, longer imaging turnaround times can contribute to delays in patient throughput and emergency department care.
The software builds on the same underlying architecture as Aidoc's FDA-cleared abdominal CT triage application, CARE Triage, extending the company's foundation model into report drafting workflows. Aidoc said First Read is intended to support quality while maintaining clinician oversight and final approval of reports.

"Radiology is entering a new era," said Elad Walach, CEO and cofounder 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."

Aidoc said this is its second FDA Breakthrough Device Designation in less than a year, following the designation granted to CARE Triage in September 2025.

The announcement comes after the company disclosed a $150 million Series E financing round in April. Aidoc says its AI platform has analyzed more than 120 million patient cases and is deployed at nearly 2,000 hospitals worldwide.

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