Noah Labs Vox,™ a voice-based algorithm that detects worsening heart failure weeks before hospitalization, has received US Food and Drug Administration (FDA) Breakthrough Device Designation (BDD).
This recognition expedites Noah Labs’ upcoming clearance and commercial activities, including an FDA trial set to launch soon, according to a company press release. The device uses a proprietary machine learning algorithm to analyze subtle vocal changes, enabling non-invasive, scalable remote monitoring for heart failure patients. With just a 5-second daily voice clip, the technology enables early intervention, reduces readmissions, and improves outcomes – accessible even in rural and resource-limited settings.
”Voice is a powerful predictor for worsening heart failure,” explains CEO and Co-founder Oliver Piepenstock. “This Breakthrough Device Designation is a pivotal milestone in Noah Labs Vox™’s path to driving early access to life-saving interventions for patients with life-threatening diseases.”
The company claims Noah Labs Vox™ is built on the world’s largest exclusive dataset of heart failure patient voice recordings, with more than three million voice samples to date. The software-only medical device has been validated across more than five multicentre clinical trials. In collaboration with Mayo Clinic, UCSF, Charité Berlin, Maastricht University Medical Center, and Hospital Clínic de Barcelona, the algorithm has demonstrated sensitivity in detecting worsening heart failure.
Prof. Felix Hohendanner, MD, PhD from Charité Berlin said, “The FDA Breakthrough Device Designation for Noah Labs Vox™ is a significant achievement for heart failure care. Early detection of clinical worsening is a central challenge in managing these patients — the ability to identify deterioration weeks before hospitalization, using nothing more than a patient’s voice, has the potential to fundamentally change how we intervene and prevent adverse outcomes.”
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