Aidoc Receives FDA Breakthrough Device Designation for AI That Drafts Radiology Reports
Aidoc, a clinical AI company serving nearly 2,000 hospitals worldwide, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its AI tool, First Read. This technology is designed to analyze chest radiographs and generate preliminary radiology report text aimed at addressing rising imaging demand.
The FDA designation comes in response to growing pressures on health systems as imaging demands outpace current capacity. A Neiman Health Policy Institute study indicated that turnaround times for outpatient imaging interpretation more than doubled between 2014 and 2023, with significant increases noted in the past two years. Delays in imaging interpretation add to patient throughput issues and emergency department congestion, with CT imaging turnaround times contributing to an increase of up to 150 minutes in patient stays and slower clinical decision-making.
First Read aims to alleviate this burden by producing high-quality draft text from imaging findings, ultimately reducing the time radiologists spend on reporting and interpretation. This allows radiologists to dedicate more time to higher-value clinical judgment and patient care. The tool builds upon Aidoc's established clinical AI platform, which has analyzed over 120 million patient cases to date.
The technology behind First Read shares the same foundation as Triage, Aidoc's FDA-cleared abdominal CT triage application, ensuring safety, reliability, and quality in the report drafting process. This marks Aidoc's second Breakthrough Device Designation in less than a year, following the designation received for CARE Triage in September 2025. The FDA uses this designation for technologies that significantly improve the diagnosis of severe diseases and fulfill unmet clinical needs, helping to expedite access to vital innovations.
Elad Walach, CEO and co-founder of Aidoc, stated that First Read signifies a shift in radiology, helping to manage increasing workloads. Robert Lookstein, MD MSc, from Mount Sinai Health System, emphasized the importance of clinically reliable AI-assisted reporting in maintaining high patient care standards amidst growing imaging volumes and workforce shortages. Aidoc's ongoing expansion includes a recent $150 million Series E financing announced in April, further strengthening its impact across the global healthcare landscape.