FDA Breakthrough Device Designation Granted to AI Tech That Drafts Radiology Reports

Aidoc has received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for First Read,* artificial intelligence (AI) technology designed to analyze chest radiographs and generate preliminary high-quality radiology report text for that analysis.

The designation occurs as imaging demand continues to outpace capacity, and interpretation remains a major bottleneck across health systems.

A recent Neiman Health Policy Institute study found outpatient imaging interpretation turnaround times more than doubled between 2014 and 2023, with the steepest increases occurring in the past two years. As imaging interpretation delays grow, health systems are facing increasing pressure on patient throughput and emergency department flow, where computed tomography (CT) imaging turnaround times can add up to 150 minutes to patient stays and delay clinical decision-making.

“Radiology is entering a new era,” Aidoc Co-Founder/CEO Elad Walach said. “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.”

First Read addresses that gap directly, according to the company. By generating high-quality draft text from imaging findings, it aims to help reduce time spent on reporting and interpretation, returning capacity to radiologists for higher-value clinical judgment and patient care.

First Read builds on Aidoc’s broader clinical AI platform, which supports care decisions across nearly 2,000 hospitals worldwide, including such health systems as Sutter Health, Wellspan Health, and Mercy, and has analyzed more than 120 million patient cases to date.

The technology is built on the same underlying architecture as Triage, Aidoc’s U.S. Food and Drug Administration-cleared abdominal CT triage application, extending the same clinically validated foundation for safety, reliability, and quality into report-drafting workflows. 

First Read is Aidoc’s second Breakthrough Device Designation in less than a year, following CARE Triage in September 2025. The FDA grants Breakthrough Device Designation to technologies that both significantly advance the diagnosis of severe diseases and represent an unmet clinical need. The designation is intended to accelerate access to life-saving innovations. 

Aidoc’s aiOS, the company’s enterprise AI operating system, delivers clinical AI directly within existing imaging and EMR workflows, enabling health systems to deploy and manage AI at scale. 

As clinical AI becomes more deeply embedded into care workflows, safety, governance, and clinical reliability become increasingly important. Errors, inconsistencies, and automation bias are known risks of generative AI in reporting workflows where every sentence carries clinical and legal weight. First Read aims to extend AI-assisted support into those workflows while increasing quality standards and preserving clinician oversight and final approval.

“Diagnostic radiologists are facing growing imaging volumes and workforce shortages, all while trying to maintain the highest standards of patient care,” said Robert Lookstein, M.D., professor of Radiology and Surgery at Mount Sinai Health System. “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 designation follows the continued expansion of Aidoc’s clinical AI platform, including a $150 million Series E financing announced in April and growing deployment across nearly 2,000 hospitals worldwide. 

Aidoc provides clinical AI technology that helps physicians make earlier, safer diagnoses by turning raw patient signals into actionable insight. The company is powered by its CARE foundation model and aiOS platform, embedding AI directly into clinical workflows, enabling health systems to deploy, manage, and scale multiple FDA-cleared solutions through a centralized operating layer. Aidoc’s technology has analyzed more than 120 million patient cases and is deployed in nearly 2,000 hospitals worldwide, supporting clinical decision-making for approximately 60 million patients annually. 

* Breakthrough Device Designation Q260882. The device is for investigational use only and has not been cleared or approved by the FDA.  First Read is a broad chest radiograph analysis solution, with Breakthrough Device Designation (Q260882) granted for four life-threatening findings.