AI-assisted report drafting for chest radiographs
Aidoc has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to First Read, an artificial intelligence solution designed to analyze chest radiographs and generate preliminary radiology report text based on imaging findings.
According to the company, the technology is intended to support radiologists by reducing the time spent drafting reports, allowing more time for image interpretation, clinical judgment, and patient care.
Aidoc cited a recent Neiman Health Policy Institute study showing that outpatient imaging interpretation turnaround times more than doubled between 2014 and 2023, with the largest increases occurring during the past two years. The company also noted that imaging delays can affect patient throughput and emergency department workflows.
Built on Aidoc's clinical AI platform
According to Aidoc, First Read extends the company's existing clinical AI platform, which is currently used across nearly 2,000 hospitals worldwide and has analyzed more than 120 million patient cases.
The report drafting solution is built on the same underlying architecture as Triage, Aidoc's FDA-cleared abdominal CT triage application. The company states that this extends its clinically validated foundation into radiology reporting workflows.
Aidoc also noted that First Read is its second technology to receive FDA Breakthrough Device Designation within the past year, following CARE Triage in September 2025. The company stated that the FDA's Breakthrough Device Designation is intended for technologies that address unmet clinical needs while advancing the diagnosis or treatment of serious diseases.
Focus on workflow integration and clinician oversight
According to Aidoc, First Read has been designed to support reporting workflows while maintaining radiologist oversight and final approval. The company also noted that safety, governance, and clinical reliability remain important considerations as generative AI becomes more widely integrated into clinical practice.
"Radiology is entering a new era," said Elad Walach, CEO and co-founder 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."
Robert Lookstein, MD MSc, Professor of Radiology and Surgery at Mount Sinai Health System, added: "Diagnostic radiologists are facing growing imaging volumes and workforce shortages, all while trying to maintain the highest standards of patient care. AI-assisted reporting has the potential to support more sustainable workflows but only if it is implemented in a way that is clinically reliable and thoughtfully integrated into practice. As these technologies mature, they will fundamentally reshape how diagnostic radiologists manage growing demand and deliver care."
Aidoc noted that First Read remains an investigational device and has not been cleared or approved by the FDA. The Breakthrough Device Designation (Q260882) applies to four life-threatening findings within the solution's broader chest radiograph analysis capabilities.
Source: Aidoc
