Aidoc Takes Generative AI to the FDA: 'First Read' Would Draft Radiology Reports for 100+ Diseases

Clinical AI company Aidoc is preparing an FDA submission for "First Read," a generative AI device that interprets chest X-rays and drafts preliminary radiology reports covering more than 100 diseases. The FDA granted the system Breakthrough Device Designation in June 2026, CEO Elad Walach told MedTech Dive in an interview published July 27.

The submission is a landmark moment for medical AI. While hundreds of narrow detection and triage algorithms have cleared the FDA over the past decade, First Read attempts something categorically harder: generating the draft radiology report itself, at a time when regulators are still building frameworks for generative AI in medicine.

Walach was candid about the bar the product has to clear. Adoption, he argues, requires the system to be "almost as good as a human for the majority of cases" — and the company estimates roughly a year and a half to complete trials and obtain clearance. Aidoc has raised more than $300 million in the past year to fund the push, including a $150 million round flagged in Rock Health's H1 2026 report.

Why it matters

Radiology has long been the tip of the spear for clinical AI, but the economics of single-finding algorithms have been challenging. A report-drafting system that works across a hundred conditions changes the value proposition entirely — and raises new questions about validation breadth and physician over-reliance that the FDA review will have to answer.

The move lands amid a busy season for imaging AI: June 2026 alone saw clearances for DeepHealth's breast arterial calcification and Mammo Dx products, Keya Medical's DeepVessel Plaque, and Cercare Medical's brain tumor segmentation software, according to Signify Research's monthly roundup.

Reporting: MedTech Dive; corroboration: Signify Research imaging AI roundup, June 2026.