AI in Healthcare

The latest on artificial intelligence transforming medicine

News stories discovered and organized by an automated pipeline. Covering clinical deployments, research breakthroughs, regulation, and industry developments.

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regulationJD Supra

FDA Updates Patient Preference Guidance, Signaling a New Era for Device Evidence

A decade after its original framework, the FDA has updated guidance on patient preference information for medical devices. The revision could make patient experience data more influential in benefit-risk decisions, especially for products serving populations with limited alternatives.

FDApatient preferenceguidancebenefit-risk
regulation

FDA interest in voice-based heart failure AI points to a new regulatory test case

A report that FDA sees promise in a voice-based AI model for heart failure adds momentum to speech as a medical signal. It also highlights a coming regulatory challenge: how to evaluate AI built on messy, real-world human behavior rather than standardized imaging or lab data.

Cardiovascular Business
FDAheart failurevoice biomarkers
regulation

FDA’s Oncology AI Program Signals a More Organized Path for Cancer Algorithms

The FDA’s Oncology Center of Excellence is putting sharper structure around how artificial intelligence will be evaluated in cancer care. That matters because oncology has become one of the fastest-moving and highest-risk settings for clinical AI, where diagnostic, treatment, and workflow tools can directly shape life-altering decisions.

fda.gov
FDAoncologyartificial intelligence
regulation

FDA’s Push Beyond Animal Testing Starts to Reshape Product Development

New FDA efforts to reduce animal testing and support alternative methods point to a broader modernization of evidence generation. For biotech and medtech companies, the shift could eventually change how preclinical packages are built, validated, and discussed with regulators.

Morgan Lewis
FDAanimal testingpreclinical development

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