Heart device trials to be conducted in Hong Kong by United InnoMed following recent funding acquisitions
AI-Powered Heart Failure Monitoring: A New Era of Single-Device Solutions
Chronic heart failure patients may soon reap the benefits of a game-changing device, a so-called "two-in-one" instrument serving both therapeutic and diagnostic functions, as revealed by founder and CEO Wang Li. This innovative device aims to save costs and lower risks associated with implanting two separate devices in most existing scenarios.
According to Wang Li, many Chinese heart failure patients are open to having a therapeutic device implanted, but cautious about additional devices for real-time monitoring. The two-in-one concept, he explains, is akin to smartphones, where we once needed a camera, a phone, and a laptop to perform today's tasks in a single device.
At present, only two implantable monitoring devices have received approval from the US Food and Drug Administration for daily pulmonary pressure monitoring from home settings, according to Li. Hong Kong could potentially become a part of the firm's international development efforts.
While specific "two-in-one" devices aren't yet prevalent in AI-driven heart failure monitoring, recent advancements focus on single-lead ECG AI systems for heart failure severity assessment and risk prediction. For instance, the Simplex Quantum and the University of Tokyo's AI system uses single-lead ECG data (even from Apple Watch) to classify heart failure severity via an HF-index, strongly correlated with BNP levels (R=0.74). This system achieved an impressive 91.6% accuracy in classifying NYHA stages with AUC up to 0.993.
Another notable development concerns portable AI-ECG predictive models, which now predict heart failure risk in multinational cohorts, making them suitable for wearable device integration. These models have been validated across diverse populations and come with frameworks for large-scale wearable trials. Although FDA approval details for these systems are yet to be disclosed, their academic advancements suggest pre-commercial stages, with the HF-index system dating back to April 2025 and Brock University’s risk-assessment tool from May 2025.
For a "two-in-one" device, current data mainly focuses on diagnostic AI paired with existing wearables rather than dual-purpose hardware. International trials are implied through multinational cohort validations, but explicit trial details remain elusive. FDA clearance for such devices would likely hinge on expanded validation studies, which are not yet fully detailed in the available information.
- Wang Li plans to expand the business of his company's "two-in-one" device, which combines therapeutic and diagnostic functions for heart failure patients, into the medical-conditions market in Hong Kong.
- The two-in-one device, similar to smartphones, aims to replace multiple devices by implanting a single device that addresses both treatment and real-time monitoring.
- In the field of AI-powered heart failure monitoring, there has been recent added focus on single-lead ECG AI systems, which are used for assessing heart failure severity and predicting risk.
- progress in AI-ECG technology has led to the development of portable predictive models capable of integrating with wearable devices for heart failure risk prediction.
- Although specific details for FDA approval of such single-lead ECG AI systems and wearable devices are yet to be disclosed, their development suggests pre-commercial stages, with some systems dating back to April 2025 and others to May 2025.
- The current development trend in heart failure monitoring technology revolves around diagnostic AI integration with existing wearable devices, but details on dual-purpose hardware for a "two-in-one" device remain scarce, implying the need for expanded validation studies for FDA clearance.
