Noah Labs Enrolls First Patients in VOICE-HF, the Pivotal Trial to Support FDA Authorization of its Voice-Based AI to Detect Worsening Heart Failure

BOSTON, October 21, 2026 – Noah Labs today announced the start of VOICE-HF, a prospective, multicenter pivotal study of Noah Labs Vox™ in adults with stage C chronic heart failure. The first participants were enrolled at Brigham and Women’s Hospital in Boston, Massachusetts, part of Mass General Brigham and a teaching affiliate of Harvard Medical School (Principal Investigator: Ameesh M. Isath, MD), and at Minneapolis Heart Institute Foundation® at Abbott Northwestern Hospital in Minneapolis, Minnesota (Principal Investigator: Mosi K. Bennett, MD, PhD).

The Monitoring Gap

Most patients have no structured monitoring at home. Daily weight scales, the most common home tool, have limited sensitivity because congestion often begins with fluid redistribution before body weight rises. When scales do signal deterioration, it is often only a few days before a hospitalization. Implantable cardiac sensors detect congestion earlier but require an invasive, costly procedure and reach only a small fraction of eligible patients. Congestion also affects the lungs, airways, and vocal folds, producing subtle but measurable changes in the voice. Noah Labs Vox™ is cloud-based software designed to detect these changes from short voice recordings captured at home on a phone or tablet, with the aim of extending remote monitoring and management to as many patients with heart failure as possible.
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"Heart failure care still depends largely on what patients can tell us at their next visit, and by then decompensation is often well underway.  If a short voice recording can reliably flag that decline early, it could transform how we monitor heart failure patients between visits, from the comfort of their own home."

Aman Shah, MD, National Principal Investigator of VOICE-HF, Medical Director of the Heart Failure Remote Monitoring Program at Tampa General Hospital’s Heart & Vascular Institute

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About VOICE-HF

Each participant records a short daily voice sample on their smartphone or tablet at home. Noah Labs Vox™ analyzes the recordings for signs of worsening heart failure. The study includes more than 15 sites in the US, Europe, and Canada. The co-primary endpoints are sensitivity for worsening heart failure events and the unexplained alert rate. VOICE-HF is led by National Principal Investigator Aman Shah, MD, an advanced heart failure and transplant cardiologist at Tampa General Hospital’s Heart & Vascular Institute.
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“VOICE-HF is the pivotal step on our path to FDA authorization. Our goal is to make remote heart failure management simple enough to reach as many patients as possible, using nothing more than a short daily voice recording.”

Leonhard Riehle, MD, Chief Medical Officer and Co-Founder of Noah Labs

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Clinical Evidence to Date

Noah Labs Vox™ is built on one of the largest proprietary datasets of heart failure patient voice recordings, with more than three million voice samples to date.

In TIM-HF3, presented as Late-Breaking Science at ESC Heart Failure 2026 and published in the European Journal of Heart Failure, the technology detected 84% of heart failure hospitalizations up to 29 days in advance. Noah Labs Vox™ has been evaluated in four clinical studies, two published and two ongoing, across more than 10 US and EU hospitals, including Mayo Clinic, UCSF, Charité Berlin, Maastricht University Medical Center, and Hospital Clínic de Barcelona.
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About Noah Labs

Noah Labs pioneers voice-based remote monitoring and care management for people living with heart failure. The company was founded in 2021 by Oliver Piepenstock, Marcus Hott, and Leonhard Riehle, MD, and is based in Boston and Berlin. Its portfolio includes Noah Labs Vox™, an investigational voice-based algorithm, and Noah Labs Ark, a CE-marked remote monitoring platform that is commercially available in Europe. Noah Labs Vox™ has been studied in collaboration with Mayo Clinic, UCSF, Charité Berlin, Maastricht University Medical Center, and Hospital Clínic de Barcelona. Noah Labs is a 2026 MedTech Innovator company, a member of the HeartX Accelerator and the American Heart Association’s Center for Health Technology & Innovation, an alumnus of the Google for Startups AI Academy, and a recipient of European Innovation Council (EIC) Accelerator funding.

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Caution: Noah Labs Vox™ is an investigational device, limited by United States law to investigational use. It is not available for sale in the United States.

Trial information: ClinicalTrials.gov NCT07870395