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Why Faster AI Submissions Mean Slower Approvals: IQVIA on Regulatory Velocity

MedTech and Pharma companies are using AI to speed up regulatory submissions, but many are finding that faster output is actually leading to more rej…

6 hours ago

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Predicting Breast Cancer Recurrence: Inside the FDA Clearance of TumorSight Risk

The 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…

10 hours ago

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Company Spotlight: DeepHealth Saige-Dx - Using Prior Exams to Drop False Positives

DeepHealth’s Saige-Dx recently received FDA 510(k) clearance for analyzing digital breast tomosynthesis (DBT) mammograms. We unpack the public summar…

11 hours ago

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Unpacking the FDA Clearance of the AIRA Kidney Algorithm

The FDA recently cleared the Artificial Intelligence Renal Assessment AIRA Version 1 for measuring kidney volume from CT scans. We break down the dev…

1 day, 4 hours ago

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Beyond Algorithms: How AI Agents Could Reshape Multimodal Cancer Diagnosis

This episode explores a pivotal paper on the shift from narrow AI tools to feedback-driven AI agents in oncology. We discuss how these systems orches…

1 day, 5 hours ago

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Can Your Smartwatch Spot Sleep Apnea? Unpacking AI and Photoplethysmography

Obstructive sleep apnea affects an enormous global population, but traditional sleep studies are expensive and inaccessible. Maya and Sam unpack a ne…

1 day, 6 hours ago

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Do AI Report Generators Actually Save Doctors Time? The 18.29-Second Reality Check

We dive into a comprehensive systematic review examining the real-world effectiveness, safety, and workflow burden of LLM-based medical report genera…

1 day, 10 hours ago

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Company Spotlight: Ibex Galen Second Read - Catching Missed Prostate Cancer

We 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…

1 day, 11 hours ago

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Company Spotlight: Brainomix 360 Hyperdensity - Automating Brain Bleed Measurement

This episode unpacks the FDA 510(k) summary for Brainomix 360 Hyperdensity, an AI tool designed to automatically flag and measure intracranial hyperd…

2 days, 3 hours ago

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The Value Inversion: Why Meaningful Outcomes Will Decide the Health AI Race

A new World Economic Forum white paper argues that health systems are evaluating AI backward. Procurement teams buy AI for efficiency, while clinicia…

2 days, 4 hours ago

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