FaceHeart wins FDA approval for AI-powered vital signs monitoring via video. Backed by Taipei Veterans General Hospital, this breakthrough in digital health positions Taiwan as a global innovator and establishes the startup as a leading smart medical device developer.
A Taiwanese startup has achieved a significant breakthrough in digital health technology. FaceHeart Inc., founded less than a decade ago, has developed FaceHeart Vitals, an AI-based software that measures physiological data using standard video cameras. In 2023, the product became the first FDA-approved solution globally to measure heart rate through video imagery.
Earlier this year, the system received international recognition at the Consumer Electronics Show (CES), winning an Innovation Award for the second time and distinguishing itself among more than 3,000 competing products.
At the end of August this year, FaceHeart was selected as one of the Forbes Asia 100 To Watch 2025. Forbes highlighted that FaceHeart "specializes in AI-powered, contactless measurement of a person’s vital signs."
CES has become a proving ground for healthcare technologies, but few companies manage to turn prototypes into FDA-cleared solutions. FaceHeart’s success demonstrates that Taiwan’s innovations are not only competitive on the global stage but also capable of meeting the stringent regulatory requirements that define credibility in healthcare.
The achievement underscores the potential of Taiwan’s smart medical device industry and highlights the importance of clinical partnerships. The success of FaceHeart’s FDA submission relied heavily on collaboration with Taipei Veterans General Hospital (TVGH), whose medical teams supported clinical trials and ensured compliance with international standards.
From Academic Research to Commercialization
The technology originated in 2012 at National Yang Ming Chiao Tung University, where Professor Bing-fei Wu and his team investigated whether subtle changes in skin coloration could be detected by a standard VGA camera (640×480 resolution) and used to calculate vital signs.
The research leveraged AI facial recognition methods to extract signals, such as blood pressure and oxygen saturation, without the need for physical sensors. After years of development, the focus shifted toward healthcare applications. In 2019, MediaTek provided Series A investment, enabling the establishment of FaceHeart Inc. and the pursuit of regulatory pathways.
Clinical Validation: Integrating Research into Routine Care
Clinical validation became the determining factor in achieving FDA approval. FaceHeart co-founder Dr. Meng-liang Chung emphasizes the contribution of TVGH’s clinical team. “We were engineers. The hospital team explained the meaning of waveforms and provided context for medical conditions. Their input was critical,” he said.
At TVGH, Vice Superintendent Dr. Wui-Chiang Lee and Health Management Center Director Dr. Shih-lin Chang coordinated trial execution. A consultation room adjacent to clinics was allocated for data collection. When patients with relevant conditions were identified, they were invited to participate in the trial immediately after their consultation.
Center to right: TVGH Vice Superintendent Dr. Wui-Chiang Lee, Health Management Center Director Dr. Shih-lin Chang, FaceHeart co-founder Dr. Meng-liang Chung.
Because the procedure required only facial video capture and no physical contact, patient acceptance was high. According to Dr. Chang, “No patient has refused once the process was explained.”
Data Quality: Multi-Device Verification and Cross-Checks
Obtaining FDA clearance required not only a sufficient sample size but also high-quality data. TVGH implemented strict verification protocols.
- Multiple devices: Each subject’s data was captured simultaneously using four to five smartphones of different brands, alongside clinical instruments such as electrocardiograms.
- Cross-referencing: In some cases, blood tests were performed to verify imaging results against laboratory values.
- Environmental conditions: Additional facilities were provided to test under varied lighting scenarios, ensuring accuracy in real-world environments.
Dr. Chang highlighted the importance of preventing false positives. “If inaccurate data are included, the entire dataset can be compromised. False alerts increase clinician workload and reduce patient trust,” he said. The rigorous standards enabled FaceHeart to refine its AI algorithms and maintain competitive precision levels.
Meeting FDA Diversity Requirements
Another challenge was meeting the FDA’s demand for diverse clinical cases across age, gender, ethnicity, and medical conditions. TVGH facilitated cross-departmental collaboration to recruit patients with a wide range of diseases, including Alzheimer’s, Parkinson’s, and multiple sclerosis.
Dr. Chung acknowledged this support: “Many required cases were outside the usual departments. Dr. Chang coordinated with colleagues across specialties to secure patient participation.”
As a result, FaceHeart compiled a dataset significantly larger than those of international competitors. For heart-rate validation, the team gathered over 500 clinically certified cases. For respiratory monitoring, the dataset was 4.5 times larger than that of a leading multinational competitor.
Market Outlook: Beyond Hospital Applications
While FDA approval positions FaceHeart Vitals for clinical use, TVGH leadership sees the broader market in consumer health.
Dr. Lee observed, “The main opportunity is outside the hospital. This technology can provide everyday health monitoring for the general population. It is contactless, easy to use, and does not require a medical environment.”
This outlook aligns with the company’s vision of accessible, preventive healthcare that can be integrated into daily life through common devices such as smartphones, tablets, or smart mirrors.
Strategic Implications for Taiwan’s Smart Medical Industry
FaceHeart’s path from academic research to FDA approval illustrates the importance of collaboration between startups, academia, and clinical institutions in advancing Taiwan’s position in the global smart medical sector.
By leveraging AI expertise, hospital networks, and regulatory alignment, FaceHeart has demonstrated that Taiwanese firms can compete internationally in emerging healthcare technologies.
As Dr. Chung summarized, the achievement validates both the company’s innovation and Taiwan’s broader capacity for industry-academia-medical collaboration. “Our clinical data exceeded international competitors. That is a direct result of working closely with TVGH,” he said.
Looking Ahead
FaceHeart’s FDA-approved imaging-based vital signs monitoring system represents a landmark for Taiwan’s smart medical device industry. Its success was enabled by technical innovation, rigorous clinical validation, and close cooperation with Taipei Veterans General Hospital.
Looking ahead, the company aims to expand beyond clinical environments into consumer health applications, offering preventive monitoring in daily life. The development sets a precedent for how Taiwan can contribute to the global healthcare technology market through integrated innovation and collaboration.
（Producer: Sophie Y. Wu／Writer: Chiyuan Chou／Adapted by Judy Lin／Editor: Lihua Wang)
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