NEW YORK, June 25, 2026
Aidoc 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 high-quality preliminary radiology report text. The designation recognizes the technology’s potential to address a critical unmet clinical need as healthcare systems worldwide face increasing imaging volumes and persistent radiologist workforce shortages. Built on Aidoc’s clinically validated CARE™ foundation model, First Read extends the company’s AI capabilities beyond image detection into radiology report drafting, aiming to improve reporting efficiency while maintaining physician oversight and final clinical decision-making.
AI Reporting Platform Targets Imaging Workflow Bottlenecks
Growing demand for diagnostic imaging has created significant reporting delays across hospitals, with recent research showing that outpatient imaging interpretation turnaround times have more than doubled between 2014 and 2023. These delays affect emergency department throughput, prolong patient stays, and postpone treatment decisions. First Read is designed to reduce this burden by automatically generating draft radiology reports from imaging findings, allowing radiologists to spend less time on documentation and more time on image interpretation and patient care. The technology leverages the same underlying architecture used in Aidoc’s FDA-cleared CARE™ Triage abdominal CT application, providing a clinically validated foundation for safe and reliable AI-assisted reporting.
CARE™ Foundation Model Expands Across Clinical Workflows
The new designation represents Aidoc’s second FDA Breakthrough Device Designation within a year, following the recognition of CARE™ Triage in September 2025. The company’s enterprise aiOS™ platform enables hospitals to integrate multiple AI applications directly into existing imaging systems and electronic medical record (EMR) workflows, simplifying large-scale AI deployment across healthcare organizations. By extending its CARE™ foundation model into report generation, Aidoc aims to improve workflow efficiency while addressing known challenges associated with generative AI, including accuracy, consistency, automation bias, and clinical governance. Every AI-generated report remains subject to radiologist review and approval, ensuring clinicians retain full responsibility for the final diagnosis.
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Aidoc Expands Global Clinical AI Leadership
The FDA designation follows a period of rapid growth for Aidoc, including a $150 million Series E financing announced earlier this year and continued expansion across nearly 2,000 hospitals worldwide. The company’s AI platform has now analyzed more than 120 million patient cases and supports clinical decision-making for approximately 60 million patients annually. By combining its CARE™ foundation model with the scalable aiOS™ operating platform, Aidoc continues to advance the adoption of enterprise clinical AI, helping health systems improve diagnostic efficiency, reduce operational bottlenecks, and support radiologists as imaging demand continues to increase globally.
Source: Aidoc press release
