Pivotal Study Validates Cordio Medical's Smartphone-Based Voice Analysis for Remote Heart Failure Monitoring

Results Presented as Late-Breaking Science at the American Heart Association (AHA) Scientific Sessions 2026

Blinded, Multicenter Study of 563 Patients Identified Risk 24.6 Days in Advance and Saw 85% Compliance and High Patient Satisfaction

CHICAGO, Nov. 9, 2026 /PRNewswire/ -- Cordio Medical, the first cardiac technology company to use voice and speech analysis for heart failure monitoring, today announced results from DETECT-HF, the pivotal validation study of its proprietary HearO™ system. Presented as Late-Breaking Science at the American Heart Association (AHA) Scientific Sessions 2026, the 563-patient blinded study found that HearO predicted more than 70% of heart failure events at an average of 24.6 days before they occurred, with high patient compliance and no device-related adverse events. The multicenter study was conducted at 46 sites, primarily in the U.S., along with participation from international academic medical centers and health systems.

Heart failure affects an estimated 7.7 million adults in the United States and is a leading cause of hospitalization among Americans over 65, with an annual national cost of over $40 billion. Patients living with the condition may experience gradual accumulation of fluid in the lungs that can eventually require hospitalization, but remote monitoring for fluid buildup remains a major challenge. Conventional approaches such as daily weight measurements can be unreliable and suffer from poor patient adherence, while more advanced monitoring technologies may require invasive procedures or dedicated devices. HearO is designed to address these limitations by detecting changes associated with fluid accumulation in the lungs through short daily voice recordings on a standard smartphone.

"As clinicians, we have long been able to hear the change in a patient's voice when they arrive at the hospital decompensated, but at that point it's already too late," said Dr. William T. Abraham, College of Medicine Distinguished Professor at The Ohio State University Wexner Medical Center, heart failure specialist, and lead author of the study. "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, without requiring an implanted device or additional hardware. This opens the possibility of bringing effective remote monitoring to a much broader heart failure population, giving healthcare practitioners an opportunity to intervene before patients require hospitalization."

HearO combines speech signal processing and AI to build a patient-specific voice model from short daily recordings on standard Android and iOS smartphones, with no additional hardware needed. The system uses this model to detect changes associated with fluid accumulation in the lungs and notifies the care team through a secure web-based portal, so clinicians can assess the need for intervention. The patented technology is language independent, and DETECT-HF subjects spoke English, Spanish, Hebrew, Russian, and Arabic.

HearO's ease of use enabled strong patient compliance and satisfaction in DETECT-HF, with patients completing 85% of their scheduled daily recordings and ranking the system with mean usability ratings of 4.7 to 4.9 out of 5. Additionally, the rate of unexplained alerts was 2.65 per patient per year, below the study's predefined goal of fewer than three.

"Nearly a decade ago, Cordio set out to pioneer the use of speech as a biomarker, and DETECT-HF marks the first blinded, prospective validation of AI-assisted voice analysis for heart failure monitoring," said Tamir Tal, CEO of Cordio Medical. "The high adherence rate we saw in DETECT-HF reinforces our vision of empowering patients to make heart failure monitoring a manageable part of their daily routines. HearO's compatibility with easily accessible standard smartphones, combined with its ease of use and deployment, creates the potential to bring effective monitoring to large and diverse patient populations, with the ultimate goal of reducing hospitalizations and improving quality of life at scale."

DETECT-HF builds on more than 1,500 patients studied across Cordio's clinical program, including earlier results published in JACC: Heart Failure and ESC Heart Failure and the COMMUNITY-HF study presented at the Heart Failure Society of America 2025 Annual Scientific Meeting.

HearO has received Breakthrough Device designation from the U.S. Food and Drug Administration, is CE marked in Europe, and approved for use in Israel. The results from DETECT-HF will support Cordio's pursuit of FDA marketing authorization through the De Novo pathway ahead of a planned U.S. launch in 2027.

The HearO system is not yet cleared for sale in the U.S. and is currently limited to investigational use.

About Cordio Medical

Cordio Medical is a cardiac technology company using voice and speech analysis for heart failure monitoring. Its patented HearO™ system turns a standard smartphone into a medical-grade monitor, detecting early signs of heart failure deterioration so clinicians can adjust treatment before patients require hospitalization. Cordio aims to bring effective, accessible, easy-to-use monitoring technology to heart failure patients everywhere. Founded by Dr. Chaim Lotan, former director of the Heart Institute at Hadassah–Hebrew University Medical Center, the company is headquartered in Or Yehuda, Israel.

For more information, visit https://www.cordio-med.com

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SOURCE Cordio Medical