Cordio Medical has validated its tool for early heart failure (HF) detection using patient voice recordings in a pivotal trial, setting a course for a regulatory filing of the smartphone-based system with the US Food and Drug Administration (FDA).
In the Israel-headquartered company’s blinded 563-patient DETECT-HF study (NCT06378632), HearO predicted over 70% of heart failure events by an average of 24.6 days before they occurred.
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Cordio presented the results during a late-breaking session at the 2026 American Heart Association (AHA) Scientific Sessions, taking place 6-9 November in Chicago.
Affecting around 7.7 million patients in the US, HF is characterised by the gradual accumulation of fluid in the lungs that can eventually require hospitalisation. According to Cordio, however, conventional monitoring approaches such as daily weight measurements can be unreliable and problematised by poor patient adherence, while more advanced monitoring technologies can require more invasive procedures.
To address these issues, HearO uses a combination of speech signal processing and artificial intelligence (AI) to build a patient-specific voice model from short daily recordings captured by smartphones to detect changes associated with fluid accumulation in the lungs. The app-based monitoring tool notifies care teams of notable changes through a web-based portal, so clinicians can assess the need for intervention.
HearO received breakthrough device designation from the FDA in 2021, followed by a European CE mark and approval from the Israeli Ministry of Health in 2022. With the pivotal trial results in hand, Cordio now plans to submit HearO for FDA clearance, with a full US market launch anticipated in 2027.
Dr William Abraham, College of Medicine Distinguished Professor at the Ohio State University Wexner Medical Center and lead study author, commented: “DETECT-HF validated that an AI-assisted voice analysis biomarker can identify deterioration weeks before a heart failure event, with sensitivity well above that reported for daily weight monitoring and comparable to invasive monitoring technologies.
“This opens the possibility of bringing effective remote monitoring to a much broader heart failure population, giving physicians an opportunity to intervene before patients require hospitalisation.”
Other medtech companies using voice recordings to assess HF include Noah Labs. The company’s Vox, which extracts and analyses acoustic features using an AI model to identify physiological changes linked to worsening HF, secured breakthrough designation from the FDA in March 2026.
