Aidoc Gets FDA Breakthrough Device Designation for Chest X-Ray Report-Drafting AI

Aidoc said on June 25 that the U.S. Food and Drug Administration has granted breakthrough device designation to First Read, artificial intelligence software designed to analyze chest radiographs and generate preliminary radiology report text. The designation is not a clearance or approval; the company's announcement says the device is for investigational use only and has not been cleared or approved by the FDA.

According to the release, the designation, numbered Q260882, was granted for four life-threatening findings. First Read is a broader chest radiograph analysis product: an Aidoc spokesperson told MedTech Dive that it is expected to generate preliminary reports on more than 100 pre-specified findings. Aidoc declined to provide the full list because the product is not yet on the market, the publication reported.

How First Read is meant to work

The software is intended to produce draft text from imaging findings so radiologists spend less time on reporting, the company said. A radiologist still must sign every report made by First Read, MedTech Dive reported. Aidoc said the product is designed to preserve clinician oversight and final approval, and acknowledged in its release that errors, inconsistencies and automation bias are known risks of generative AI in reporting workflows.

First Read is built on the same underlying architecture as Aidoc's FDA-cleared abdominal CT triage application, the company said, and is separate from its products that triage and prioritize radiologists' worklists, according to MedTech Dive.

"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," said Elad Walach, Aidoc's chief executive and co-founder.

Second designation in under a year

The company said First Read is its second breakthrough device designation in under a year, following one for CARE Triage in September 2025. In its release, Aidoc described the designation as going to technologies that significantly advance the diagnosis of severe diseases and represent an unmet clinical need. MedTech Dive noted that the designation prioritizes devices for FDA review and provides more opportunities for feedback.

Aidoc said its clinical AI platform is used across nearly 2,000 hospitals worldwide and has analyzed more than 120 million patient cases. The company announced a $150 million Series E financing round in April.

The designation comes as the FDA has not laid out a framework for regulating generative AI devices, MedTech Dive reported, noting that the agency issued draft guidance in early 2025 on AI transparency, bias and post-market monitoring that it has not finalized. Aidoc did not give a timeline for an FDA submission.