Circadian AI: Detecting Heart Disease with AI-Powered Heart Sound Analysis | MTW North America 2026

Why It Matters

By enabling accurate, low‑cost heart disease screening on a smartphone, Circadian AI could dramatically reduce undiagnosed cardiovascular deaths in underserved regions and open a multi‑billion‑dollar market for AI‑based diagnostics.

Key Takeaways

• AI analyzes iPhone heart sounds to detect cardiac disease.
• 91% sensitivity, 99.4% specificity in Indian hospital trials.
• Only 5,000 cardiologists are available for 1.4 billion Indians.
• Tool flagged asymptomatic patients with mitral and ventricular issues.
• FDA 510(k) filing planned for late 2026, global expansion.

Summary

Circadian AI showcased its AI‑driven platform that turns a standard iPhone into a cardiac diagnostic tool, aiming to close the massive gap in cardiovascular disease detection, especially in low‑resource settings. The company highlighted that India, with only 5,000 cardiologists for 1.4 billion people, sees 64.5% of heart‑related deaths go undiagnosed, a pattern echoed worldwide where 20.5 million annual CVD deaths occur, 75% in low‑ and middle‑income countries.

In clinical validation across three government hospitals, the software achieved up to 91% sensitivity, 99.4% specificity and 96% overall accuracy by recording a seven‑second heart sound at the fifth intercostal space and instantly delivering a diagnostic report. Real‑world cases included asymptomatic patients later confirmed with mitral regurgitation, severe left‑ventricular dysfunction, and multiple valve abnormalities, demonstrating the tool’s ability to surface hidden pathologies.

Founder‑CEO Siddharth Mandala emphasized that the solution’s software‑only nature lets it reach rural clinics and resource‑constrained environments where traditional echo or ECG machines are unavailable. He cited the successful detection of previously unknown cardiac issues as proof that early intervention can be dramatically accelerated.

Looking ahead, Circadian AI plans a late‑2026 FDA 510(k) submission, broader trials across Indian demographics, and expansion into Ghana and the United States. The company is seeking hospital partners and investors, positioning itself to disrupt cardiac diagnostics by making high‑quality screening accessible via ubiquitous mobile devices.

Original Description

Can a smartphone help identify heart disease before symptoms become life-threatening?

At MedTech World North America 2026, Siddarth Nandyala, Founder and CEO of Circadian AI and the youngest presenter on the MedTech World stage, showcased how the company is using AI-powered heart sound analysis to improve access to cardiovascular screening.

In this company showcase, Nandyala explains how Circadian AI analyzes cardiac oscillations recorded on a smartphone to help clinicians identify potential cardiac abnormalities in seconds.

Key topics include:

• AI-powered heart sound analysis using a smartphone

• Addressing the global shortage of cardiology specialists

• Early detection of cardiovascular disease in underserved communities

• Clinical validation across government hospital sites in India

• Real-world patient cases identified through Circadian AI screening

• Expanding access to cardiac diagnostics in low-resource settings

Circadian AI is focused on making cardiac screening more accessible, helping healthcare providers identify patients who may require further evaluation and intervention.

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