The US Food and Drug Administration (FDA) has granted Noah Labs breakthrough device designation for a remote patient monitoring (RPM) tool that analyses voice recordings to detect worsening patient heart failure (HF) rates.

Noah Labs’ Vox is a software-based medical device that extracts and analyses acoustic features using an AI model to identify physiological changes linked to pulmonary congestion and fluid overload. Suitable for a range of settings, patients submit their voice recording via a smartphone or tablet.

Vox has currently been validated in five multicentre clinical trials in collaboration with partners including the Mayo Clinic and the University of California San Francisco (UCSF).