AI-based Software as a Medical Device

[INQ. NO. 2604E05] a.cure Co., Ltd. is a digital healthcare company developing AI models that predict disease risk based on voice analysis. Established in June 2024 by a team with experience in developing Korea’s first digital therapeutic device, Somzz, the company is currently advancing by developing AI-based Software as a Medical Device (SaMD), Heart to Voice, designed to analyze the voices of heart-failure patients and high-risk groups. The solution aims to detect early warning signs, prevent emergency events, and reduce hospital readmissions.
Rather than focusing on a single product, a.cure is building a comprehensive digital medical ecosystem that spans early screening ―> diagnostic support ―> post-discharge monitoring. In the long term, the company plans to integrate traditional pharmacological treatments such as diuretics, smartphones, and mobility services to create cross-industry healthcare synergy.
a.cure is currently conducting exploratory clinical trials to further refine Heart to Voice. In the first half of this year, a.cure is advancing with the development of a 90-day prescription-based monitoring AI SaMD for heart failure patients following hospital discharge. In the second half of the year, the company aims to apply for approval through the Korean Ministry of Food and Drug Safety’s Integrated Review Program for Innovative Medical Devices.

Global expansion efforts are also underway. In the first half of the year, a.cure plans to conduct Proof-of-Concept (PoC) projects in collaboration with Medstown in India and PMK Group in Singapore, integrating Heart to Voice into local chronic-disease management platforms. In the second half of 2026, the company intends to apply for the U.S. FDA Breakthrough Devices Program (BDP).
a.cure recently unveiled its 90-day prescription monitoring AI SaMD for post-discharge heart failure patients, and is currently seeking domestic and international distribution and sales partners. The company will conduct product demonstrations and technical briefings targeting pharmaceutical companies, diagnostic firms, and digital health platform operators, while exploring strategic collaborations for overseas PoCs and commercialization.

Digital Cardiopulmonary Product
Heart to Voice is a digital medical product that analyzes approximately 10 seconds of speech using only a smartphone, without requiring additional medical equipment. The AI quantifies biological signals embedded in vocal data ― such as breathing patterns, subtle vocal tremors, and acoustic energy distribution ― closely related to cardiopulmonary function. Based on this analysis, heart-failure severity is classified into four stages ― Normal, Mild, Moderate, and Severe. Exploratory clinical trials have demonstrated predictive performance with an AUC of approximately 95%.

Because the solution is non-invasive and allows for repeated measurements, it can be used in daily life outside the hospital setting. This makes it particularly suitable for continuous monitoring after discharge and for early detection in high-risk populations, positioning it as a next-generation digital-health technology.
Globally, heart failure affects an estimated 120 million people. Approximately 24 million patients are located across five major markets: Korea, the United States, China, Japan, and Singapore. Considering patient population size, as well as digital health adoption, and healthcare accessibility, a.cure has identified the United States, Japan, China, India, Indonesia, and Singapore as key target markets. The company plans direct SaMD entry into the United States and Japan, while pursuing a phased market approach in China, India, Indonesia, and Singapore through partnerships with chronic-disease management platforms based on an “early cardiac-risk detection” wellness service model.
“We will continue enhancing the accuracy of our AI-based heart failure severity model and expanding global validation datasets to strengthen our technological credibility. Through expanded domestic and international distribution partnerships and participation in major global exhibitions ― including MEDICA 2026, SWITCH 2026, and CES 2027 (Innovation Awards application) ― we will accelerate our growth as a global leader in medical AI,” explained the company’s CEO.
 
 
korean-electronics.com | Blog Magazine of korean electronics, brands and Goods