9+1AI Earns FDA Breakthrough Device Designation for AI-Driven ECG-Based BNP Estimation Tool for Early Heart Failure Detection
This precise, non-invasive screening tool is designed for patients with or at risk for heart failure and is intended to support earlier identification of cardiac dysfunction in a variety of care environments.
MEMPHIS, Tenn. – April 19, 2025 – 9+1AI, an AI-driven digital health company pioneering artificial intelligence in cardiovascular care, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its software that estimates B-type natriuretic peptide (BNP) levels from single-lead electrocardiograms (ECG). This precise, non-invasive screening tool is designed for patients with or at risk for heart failure and is intended to support earlier identification and proactive management of cardiac dysfunction in a variety of care environments.
Heart failure affects over 6 million adults in the U.S. and remains a leading cause of hospitalization and readmission. Clinical guidelines recommend BNP testing to help assess cardiac function and guide treatment, yet traditional BNP testing is underutilized due to its reliance on in-person lab visits and blood-based diagnostics.
The 9+1AI software analyzes routine ECG signals—whether recorded in the clinic or captured from a smartwatch like Fitbit—to classify BNP levels. When elevated levels are detected, the system notifies the care team, enabling lab-free, real-time insights that support timely clinical decision-making. Designed to expand access to critical biomarker information, the technology helps identify patients who may benefit from further evaluation, whether in the clinic or at home.
"This designation is a major step toward more accessible, proactive care for individuals living with—or at risk for—heart failure. By delivering BNP insights from a simple ECG, we're equipping care teams to detect early warning signs and intervene before deterioration occurs."
— Oguz Akbilgic, DBA, PhD, Chief Science Officer of 9+1AI
The FDA Breakthrough Device Designation is reserved for technologies that may provide more effective diagnosis or treatment of life-threatening or irreversibly debilitating conditions. With this designation, 9+1AI will benefit from prioritized review and collaborative engagement with the FDA to accelerate regulatory development.
9+1AI is currently advancing clinical validation and expanding strategic partnerships to support broader adoption of its technology across diverse care environments.
About 9+1AI
9+1AI is an AI-driven health technology company committed to advancing accessible, predictive diagnostics for cardiovascular and maternal health. A Phase I winner of the 2022 NIH RADx Maternal Health Challenge, the company develops software tools that leverage everyday bio-signals—such as the ECG—to help clinicians detect disease earlier and deliver proactive, personalized care. 9+1AI's mission is to make life-saving insights universally accessible by unlocking real-time data that enables earlier intervention and improves quality of life for those living with or at risk of heart disease.
References
- American Heart Association. Heart Disease and Stroke Statistics — 2023 Update.
- Bozkurt B, et al. Universal Definition and Classification of Heart Failure: A Report of the HFSA/ESC/ACC/AHA. J Card Fail. 2021.
- Yancy CW, et al. 2017 ACC/AHA/HFSA Focused Update of the 2013 Guidelines for the Management of Heart Failure. Circulation. 2017.
- Braunwald E. Biomarkers in Heart Failure. N Engl J Med. 2008.