Aidoc Receives FDA Breakthrough Device Designation for AI That Drafts Radiology Reports

First Read is designed to help radiologists meet rising imaging demand, extending Aidoc's clinically validated CARE™ foundation model into report drafting workflows.

NEW YORK, June 25, 2026 /PRNewswire/ -- Aidoc, the clinical AI company supporting diagnostic decisions across nearly 2,000 hospitals worldwide, today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation to First Read¹, AI designed to analyze chest radiographs and generate preliminary high-quality radiology report text for that analysis.

The designation comes 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 CT imaging turnaround times can add up to 150 minutes to patient stays and delay clinical decision-making.

First Read is designed to address that gap directly. 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 leading health systems such 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 FDA-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 under 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 is designed to extend AI-assisted support into those workflows while increasing quality standards and preserving clinician oversight and final approval.

"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."

"Diagnostic radiologists are facing growing imaging volumes and workforce shortages, all while trying to maintain the highest standards of patient care," said Robert Lookstein, MD MSc, Professor of Radiology and Surgery, 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 designation follows 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.

About Aidoc

Aidoc is a global leader in clinical AI focused on helping physicians make earlier, safer diagnoses by turning raw patient signals into actionable insight. The company is powered by its breakthrough 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 each year.

¹ 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.

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SOURCE Aidoc