Episode Details

This episode unpacks the FDA 510(k) summary for Brainomix 360 Hyperdensity, an AI tool designed to automatically flag and measure intracranial hyperdensities on CT scans. We explore its clinical workflow, its performance metrics, and a fascinating pre-approved plan that allows the algorithm to be updated without new FDA submissions.

Key points

• Brainomix 360 Hyperdensity is a software-only medical device cleared to automatically label, visualize, and quantify intracranial hyperdensities on non-contrast CT head scans.
• The target population is adults who undergo a head scan for suspected acute intracranial hemorrhage as part of a primary diagnostic workup.
• The FDA cleared it based on substantial equivalence to the Viz HDS device, though Brainomix chose not to include outputs for lateral ventricle volume or midline shift.
• Performance testing showed a mean absolute error of less than 7.5 mL for total volume and a DICE score greater than 70%, though the summary omits the exact size of the test dataset.
• The clearance includes a Predetermined Change Control Plan, allowing Brainomix to retrain model weights and adjust probability thresholds in the future without a new premarket notification.

Source: FDA 510(k) summary K260406: Brainomix 360 Hyperdensity (Brainomix) - U.S. Food and Drug Administration, 2026

This episode is an AI-generated conversation summarising a public document; the hosts' voices are synthetic. It is for information only and is not medical advice. Always refer to the original source.

Full transcript: https://ai-in-medicine-podcast.vercel.app/episodes/company-spotlight-brainomix-360-hyperdensity-automating-brain-bleed-me-d66dc3