AI Detects Heart Failure from a Five-Second Voice Clip

Noah Labs has received FDA Breakthrough Device Designation for Vox, an AI-powered diagnostic tool that detects worsening heart failure by analyzing subtle changes in a patient's voice. The designation was granted in March 2026, fast-tracking the path to FDA clearance and U.S. commercialization.

Vox is a software-only medical device that uses a proprietary machine-learning algorithm to analyze a five-second daily voice recording. The system can detect signs of deteriorating heart failure up to three weeks before a patient would typically require hospitalization, providing clinicians with an early, non-invasive warning signal.

The technology has been validated across five multicenter clinical trials in partnership with Mayo Clinic, UCSF, Charité Berlin, Maastricht University Medical Center, and Hospital Clínic de Barcelona. Noah Labs plans to initiate an FDA clinical trial in the near future.

Heart failure is one of the most expensive conditions to treat in global healthcare, largely because deterioration is often caught late. An accessible voice-based monitor that can warn weeks in advance has the potential to significantly reduce acute hospitalizations and improve patient outcomes.

FDA Breakthrough Device Designation means the agency will prioritize its review, typically cutting the approval timeline roughly in half compared to standard processing.