Aidoc has received FDA Breakthrough Device Designation for First Read, an artificial intelligence (AI)-powered solution designed to support chest X-ray analysis and generate preliminary radiology report text.
The technology aims to improve diagnostic workflows by helping radiologists manage increasing imaging demands and reporting pressures.
The designation addresses growing challenges faced by healthcare systems, including rising imaging volumes and delays in report turnaround times.
First Read is designed to create draft reports from imaging findings, helping reduce administrative workload and allowing radiologists to focus on complex clinical decisions.
The solution is built on Aidoc’s established clinical AI platform, which is used across nearly 2,000 hospitals worldwide and has analysed more than 120 million patient cases.
It also leverages the same technology foundation as Aidoc’s FDA-cleared Triage application for abdominal CT imaging, supporting reliable performance and integration into healthcare workflows.
First Read represents Aidoc’s second Breakthrough Device Designation within a year, following CARE Triage in 2025.
The FDA’s Breakthrough Device programme recognises technologies that address significant clinical needs and have the potential to improve patient care.
Integrated with Aidoc’s aiOS™ enterprise AI operating system, First Read is designed to enable scalable AI adoption while maintaining clinician oversight and safety standards in radiology reporting.
