Healthcare IT
FDA Won't Let Radiology AI Skip Premarket Review. Here's Why.
FDA formally denied Harrison.ai's bid to let experienced radiology AI vendors skip 510(k) review for new tools. Why regulators and radiologists said no.
FDA
Healthcare IT
An AI Passed Radiology's Certifying Exam. It Can't Practice Yet.
Harrison.ai's Rad 1.5 is the only AI model to pass the FRCR 2B Short Case, the exam standard that certifies UK radiologists — and anyone can try it today, free, no waitlist. What it actually does, what the benchmark fine print says, and how far away US clinical use really is.
Healthcare IT
FDA's Elsa 4.0 and the 40-System HALO Consolidation
The FDA shipped Elsa 4.0 on May 6 alongside HALO, a platform that consolidates more than 40 separate FDA application and submission systems into one. The capabilities are real and the architecture is defensible. The hallucination track record from Elsa 1.0 is still on the public record.