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.
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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).
The tool is currently going through the European Union’s Medical Device Regulation (EU MDR) certification process. Supported by data from Noah Labs’ PRE-DETECT-HF trial (NCT07443969), the company anticipates receiving EU approval by mid-2026.
With FDA breakthrough designation in hand, Noah Labs said it expects its US commercial activities, including its pending regulatory approval with the agency, to be expedited. The company added that an FDA trial will kick off soon.
Noah Labs CEO, Oliver Piepenstock said: “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.”
GlobalData analysis reveals that the global patient monitoring market is growing at CAGR of 1.9% and is forecast to reach a valuation of around $25.9bn in 2035, up from $21.4bn in 2025.
HF is the prevalent cause of hospital admission globally. The condition affects approximately six million Americans, with prevalence projected to increase by 46% and direct medical costs to reach $53 billion by 2030.
Noah Labs software-only medical device represents a departure from other currently marketed RPM tools for HF, in which monitoring blood pressure to determine the likelihood of impending HF is the dominant method.
Abbott’s CardioMEMS HF system is a wireless sensor implanted into the pulmonary artery that monitors a patient’s blood pressure and heart rate, providing healthcare professionals (HCPs) with remote readings that allow them to act on early warning signals of cardiac exacerbations before symptoms escalate.
CardioMEMS gained FDA clearance in 2014, while the UK’s National Institute for Health and Care Excellence (NICE) formally recommended the system in March 2026, paving the way towards CardioMEMS use within the UK National Health Service (NHS). Meanwhile, Abbott’s next-generation version CardioMEMS Hero obtained FDA clearance in March. Working in conjunction with CardioMEMS implanted sensor, patients lay with their back centred on the Hero reader to have their blood pressure read. There have so far been no head-to-head studies comparing devices like Abbott’s to Noah Labs’ Vox.
According to a GlobalData market model, GE HealthCare held the leading position in the cardiovascular monitoring device market in 2025 with a share of 26.6%, followed by Suzuken and Baxter in second and third place, with market share of 17.9% and 11.5%, respectively. GE HealthCare’s leading US market position is predominantly due to its provision of enterprise-scale hospital infrastructure solutions for RPM for HF and other conditions, including its portfolio of ECG machines and bedside monitors.
