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FDA Clearances: AI in Medicine podcast episodes
What the FDA's public summaries say about cleared AI-enabled medical devices.
- Predicting Breast Cancer Recurrence: Inside the FDA Clearance of TumorSight Risk9 October 2026 · 15 minThe FDA recently cleared TumorSight Risk, an AI software that analyzes MRI and clinical data to predict the 5- and 10-year recurrence risk for breast cancer patients. Maya and Sam unpack the 510(k) summary, exploring…
- Company Spotlight: DeepHealth Saige-Dx - Using Prior Exams to Drop False Positives9 October 2026 · 14 minDeepHealth’s Saige-Dx recently received FDA 510(k) clearance for analyzing digital breast tomosynthesis (DBT) mammograms. We unpack the public summary to see how this AI tool uses prior screening exams to reduce false…
- Unpacking the FDA Clearance of the AIRA Kidney Algorithm8 October 2026 · 17 minThe FDA recently cleared the Artificial Intelligence Renal Assessment AIRA Version 1 for measuring kidney volume from CT scans. We break down the device's technical workflow, its impressive clinical performance…
- Company Spotlight: Ibex Galen Second Read - Catching Missed Prostate Cancer8 October 2026 · 11 minWe unpack the FDA 510(k) summary for Galen Second Read by Ibex Medical Analytics. This episode explores how this cloud-hosted AI acts as a background safety net for pathologists, analyzing prostate biopsies initially…
- Company Spotlight: Brainomix 360 Hyperdensity - Automating Brain Bleed Measurement7 October 2026 · 13 minThis 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…
- Company Spotlight: Aidoc BriefCase-Triage - Triage Time Cut to 1.09 Minutes6 October 2026 · 14 minWe unpack the FDA 510(k) summary for Aidoc's BriefCase-Triage, a cloud-based AI tool cleared in May 2026. Listeners will learn how it performs in flagging large and medium vessel occlusions, the real numbers behind its…
- Company Spotlight: Viz.ai Viz Subdural+ - Quantifying Brain Scans with AI6 October 2026 · 12 minWe unpack the FDA 510(k) clearance summary for Viz Subdural+, an AI tool designed to automatically label and measure collections in the subdural space from brain CT scans. Listeners will learn how the algorithm…
- Will AI Redefine Burn Triage? Unpacking the FDA's DeepView AI De Novo Order6 October 2026 · 18 minThe FDA has granted De Novo classification to Spectral MD's DeepView AI System, a software that predicts burn wound healing. Maya and Sam unpack the device's indications, the strict special controls required, and what…
- FDA Clears Bayesian's AI Sepsis Tool: Analyzing the Data Behind the 510(k)5 October 2026 · 18 minThe FDA has granted 510(k) clearance to the Bayesian Health Sepsis Flagging Device, a continuous AI monitor that uses 115 electronic health record inputs to predict sepsis risk. Maya and Sam break down the 10-page…