An electrocardiogram (ECG) is a common physiological monitoring device used in medicine. However, conventional ECGs must be operated by medical professionals and are monotonous and time-consuming to use. The PCA 500 developed by QT Medical, a company based in the United States, is a medical-grade 12-lead ECG system that is easy to use and can be operated by a layperson following simple instructions. The entire process takes no more than a minute. The recorded data is sent to the backend via a mobile device and is available to the physician in the cloud for case management and telemonitoring. In terms of accuracy, the device has been approved by the U.S. Food and Drug Administration (FDA), and clinical trials have proven that its performance is on par with high-end resting ECGs in terms of accuracy.
Jackal Chen, senior vice president of QT Medical, pointed out that cardiovascular diseases pose a major threat to human health, with a mortality rate even higher than that of cancer. Fast and affordable, 12-lead ECGs have long been used for preliminary diagnosis and disease classification. According to the medical guidelines set forth by the American Heart Association (AHA), the performance of a 12-lead ECG is recommended when an individual experiences chest pain or tightness. Although these common symptoms may seem harmless, they are often the sign of heart disease. A 12-lead ECG provides an initial screening of heart conditions and helps the physician make a diagnosis.
However, as the 12-lead ECG machines are located in hospitals and an ECG screening is usually only part of a complete medical examination, the test must be performed in a hospital. This time-consuming and inconvenient medical procedure often discourages people from being examined and reduces the chances of patients receiving the necessary treatment. In response to this issue, the PCA 500, a medical-grade 12-lead ECG system from QT Medical, was developed specifically to address this problem. According to Jackal Chen, QT Medical's team is committed to making 12-lead ECG devices and services more accessible and user-friendly in small- and medium-sized clinics, community centers, private homes, and even public places. The company wants its product placed similarly to automated external defibrillators (AEDs) commonly found on the street to enable the rapid proliferation of hospital-grade ECG services.
The PCA 500, a medical-grade 12-lead ECG system from QT Medical, stands out for its simplicity. The device consists of a patented one-piece electrode sensor and an ECG recorder, coupled with a mobile app and a cloud-based platform. Users only need to follow the visual instructions and attach the patented ECG electrode sensor to their body. The device then automatically measures the data and it wirelessly to the cloud platform via the app. Finally, the data and preliminary interpretation reports are received by the physician for evaluation.
On the whole, the medical-grade 12-lead ECG devices from QT Medical are handy, hygienic, efficient, accurate, and of high quality. The intuitive design of the system makes it easy for an average person or patient to use it comfortably and without special training, while achieving the same accuracy as a standard hospital ECG machine. The compact design and patented one-piece disposable strips effectively reduce the risk of disease transmission through direct contact and avoid the risk of misalignment and misdiagnosis associated with the complicated lead wire placement of traditional ECG devices. This ensures convenience and data accuracy, as well as drastically minimizes the time required for the procedure. All ECG data is encrypted and transmitted securely to the HIPAA- and GDPR-compliant cloud-based management system, which enables real-time case management and provides reports in PDF format for easy aggregation and analysis.
Jackal Chen further explained that the development of the product is technically difficult, as the shape of the strips, their position, and the software design need to be fine-tuned in a series of clinical trials to obtain accurate data swiftly. In addition, once completed, the product must undergo rigorous testing and certification to prove its safety and efficacy. Currently, the PCA 500 medical-grade 12-lead ECG system is being used in clinical trials in a variety of different settings and applications. In addition, QT Medical has developed various business models to accommodate the laws and cultures of different countries. In the vast United States, for example, the company works with health facilities to deliver the devices and test strips to patients by mail. Patients operate the device themselves and the data is automatically sent to the cloud-based platform for physicians to analyze. The company is also working with prison authorities in the United States, where the devices are operated by prison staff to address the shortage of medical staff in prisons. As for the Taiwanese market, the device is not only used in hospitals but also in ambulances and telemedicine. Patients can test themselves at home or in a community center and enjoy the benefits of telemedicine and mobile healthcare within the established healthcare system.
Since its market launch, the PCA 500 medical-grade 12-lead ECG system has garnered praise in the healthcare industry. In addition to being innovative and practical, solving many of today's medical challenges, Jackal Chen believes that the startup ecosystem in Taiwan and the support from relevant institutions have also contributed greatly to the company's successful growth.
Jackal Chen pointed out that the Taiwan branch of QT Medical was established in 2015. Over the past 8 years, an increasingly dynamic startup ecosystem has developed in Taiwan. The policy resources of government agencies and the expertise of business accelerators have also grown rapidly. These resources and policies have been extremely helpful for startups to gain access to the market. The Taiwan Tech Arena, for example, has brought several startups to visit Japanese business leaders and medical institutions. Institutional support has improved the startup teams' standing in dialogue with the other side, allowing for more comprehensive and smoother communication. As a result, new communication channels have been created, opening up the local market.
Going forward, QT Medical aims to optimize its products further and expedite product marketing efforts. In the near future, the company will focus on the markets of developed countries and actively collaborate with various agencies to expand the application potential of its products, realizing the vision of mobile healthcare and telemedicine.
QT Medical’s PCA 500 is the world’s most portable medical-grade 12-lead ECG system. The patented ECG electrode strips are FDA-approved and can be handled by non-professionals, opening new possibilities for telemedicine applications and cardiac screening.
Photo: QT Medical