Noah Labs' Voice AI for Worsening Heart Failure Gets FDA Breakthrough Device Designation

Noah Labs said on March 25 that the U.S. Food and Drug Administration has granted breakthrough device designation to Noah Labs Vox, software that analyzes a short daily voice recording to detect worsening heart failure, the Boston- and Berlin-based company said in a release.

Breakthrough device designation is meant to speed the development and review of qualifying devices. It is not a marketing authorization: Vox has not been cleared or authorized by the FDA. The company said the designation will expedite its "upcoming clearance and commercial activities, including the company's upcoming FDA trial set to kick off shortly."

How the software works

According to the company, Vox is a software-only medical device that uses a machine learning algorithm to analyze subtle changes in a patient's voice from a 5-second daily recording, with no additional hardware. Noah Labs says the algorithm can detect deterioration weeks before a hospitalization, so that clinicians can intervene earlier.

Medical Device Network reported that Vox extracts and analyzes acoustic features with an AI model to identify physiological changes linked to pulmonary congestion and fluid overload, and that patients submit their recordings by smartphone or tablet.

The company said the algorithm is built on more than three million voice samples from heart failure patients and has been validated in more than five multicenter clinical trials with partners including Mayo Clinic, UCSF, Charité Berlin, Maastricht University Medical Center and Hospital Clínic de Barcelona. Noah Labs described the algorithm's sensitivity as "exceptional" but did not publish performance figures in the release.

"Voice is a powerful predictor for worsening heart failure. 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," said Oliver Piepenstock, the company's chief executive and co-founder.

Regulatory plans and competition

Medical Device Network reported that Vox is also going through certification under the European Union's Medical Device Regulation and that, supported by data from the company's PRE-DETECT-HF trial, Noah Labs expects EU approval by mid-2026. The company already sells Noah Labs Ark, a CE-marked remote monitoring platform used at European clinical sites.

The outlet noted that the dominant approach in remote heart failure monitoring relies on pressure measurements, citing Abbott's CardioMEMS HF system, a sensor implanted in the pulmonary artery. It reported that there have been no head-to-head studies comparing such devices with Vox.

Prof. Felix Hohendanner of Charité Berlin said in the release that "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."

Noah Labs was founded in 2021 by Oliver Piepenstock, Marcus Hott and Leonhard Riehle. The company said it has raised a combined $12 million in public grants and private equity funding, including grant funding from the European Innovation Council Accelerator.