Aidoc's chest X-ray reporting tool earns FDA Breakthrough Device designation
An artificial intelligence-powered tool that assists with chest radiograph interpretation and report drafting has just been granted Breakthrough Device designation from the U.S. Food and Drug Administration.
First Read analyzes chest radiographs and produces high quality draft report text to help radiologists complete interpretations more efficiently while maintaining direct oversight. Chest X-rays are the most frequently performed imaging exam in the world and can account for a significant portion of a radiologist’s workload, depending on the setting. Aidoc hopes the product can help ease this burden and allow readers to shift their focus on more complex, time-intensive interpretations.
“Radiology is entering a new era,” Elad Walach, CEO and co-founder of Aidoc, said in a statement June 26. “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.”
The AI program was built on the same technology platform as Aidoc's FDA-cleared abdominal CT triage application. It was designed to integrate directly into existing imaging and electronic medical record workflows through the company's enterprise AI operating system, eliminating the need for downtime due to installation. The software incorporates safeguards to support clinical reliability and minimize risks such as generative AI errors and automation bias, and radiologists maintain the final review and approval of all reports.
“Diagnostic radiologists are facing growing imaging volumes and workforce shortages, all while trying to maintain the highest standards of patient care,” added Robert Lookstein, MD MSc, professor of radiology and surgery at Mount Sinai Health System, New York. “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.
The Breakthrough Device Designation is Aidoc's second in less than a year. Its tools are now deployed across nearly 2,000 hospitals worldwide.
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In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.