With The World’s Only FDA Approved Medical Grade Home Use 12-Lead ECG Monitor, QT Medical Writes A New Chapter in the Treatment of Heart Disease

19 Jan

Healthcare providers attach ten cold electrodes to an infant’s delicate torso. As the examination proceeds, the infant’s squirming and intense crying interfere with the electrocardiogram readings, thus delaying the diagnosis.

While cardiovascular diseases kill 60 million people annually, ECGs have not significantly changed

According to US statistics, approximately 1 out of every 2,000 babies is born with Long QT Syndrome (LQTS) resulting in 400 neonatal deaths a year. Without an adequate ECG, LQTS cannot be diagnosed in time to prevent sudden death. This grim scenario represents what Dr. Ruey-Kang Chang has had to face almost daily.

“A lack of a suitable electrocardiogram for infants has been frustrating. We usually have to modify available adult conductive pads to fit a baby’s smaller size. Additionally, babies often do not cooperate with clinicians, making a good physical examination difficult,” Dr. Chang says. Dr. Chang, who grew up in Taiwan, currently serves as a professor at the University of California, Los Angeles (UCLA) with 20 years of experience as a cardiologist. Notably, his experience as a student researcher in pediatrics and pediatric cardiology has cemented his determination to improve the ECG.

▲QT Medical founder/UCLA professor Dr. Ruey-Kang Chang has been a practicing cardiologist for approximately 20 years and possesses over 15 patents. He launched two startups to improve upon the 12 Lead ECG monitor for pediatric cardiology.

Dr. Chang and his colleagues often wonder why nobody has yet to improve upon something that obviously needs an upgrade. Seeing savable lives that eventually perished because they did not have better instruments has saddened Dr. Chang deeply. LQTS and other cardiovascular diseases could all benefit from a better electrocardiogram. According to CDC, each year about 610,000 people die of heart diseases in the United States. In other words, one in every four American deaths is cardiovascular-related. The most dangerous aspects of heart diseases lie in their insidious nature and abrupt onset. Early detection has been a research focus, but progress has been limited.

One-Lead OTC Device Lacks Accuracy and Precision, but a 12-Lead ECG Must Overcome Challenges Ahead

Upon closer inspection of existing cardiac monitoring devices, one could quickly realize not much has changed in over 100 years. While there are wearable smart medical devices nowadays, electrocardiography progress has stayed relatively stagnant. Take Apple Watch series 4 for example; although it provides long-term monitoring of chronic heart conditions and heart rate, it is still considered an OTC electrocardiogram. The information obtained is not regarded as an ECG in the traditional sense, but an electromagnetic pulse within a specified period. Furthermore, whereas the traditional ECG has twelve leads, Apple Watch contains only one lead to screen only for cardiac arrhythmias.

Dr. Chang indicates that if one equates using a one lead ECG to installing a security camera at home, then employing the 12 lead ECG would be like putting cameras in every corner of the room. Notably, only a 12 lead ECG, not its one lead counterpart; can detect myocardial ischemia, heart attack, cardiomyopathy, myocarditis, pericardial tamponade, etc. Hence, a medical grade home use 12 lead ECG data will prove vital for timely detection of heart diseases.

A wearable, smart 12-lead ECG monitor will still need to clear major obstacles before it can become mainstream. On the one hand, medical grade devices often involve a longer detection time; on the other hand, the high R&D expenses usually make them less price competitive, and thus harder to gain market share. The greatest hurdle for any potential new marketable medical device has always been getting FDA approval. A new medical product must properly address the issues concerning safety, durability and warranty. All the above-mentioned factors have contributed to the relatively slow development of medical grade devices in general.

The World’s Only FDA Approved Home Use 12-lead ECG, Writing a New Chapter for Treating Heart Diseases

The arrival of QT ECG represents a new breakthrough for a smart ECG monitor. The five-year-old QT Medical will launch a wearable ECG, the size of a deck of cards, during the first quarter of 2019. It is currently the world’s only FDA-certified medical equipment (K180157 T-FDA)—medical grade, home use 12 lead ECG.

QT ECG transforms traditional ECG’s ten conductive pads into a simple pad with a size range (S-XL). A patient can connect the device to a smartphone or a tablet at home without the assistance of health professionals. All the important ECG data that are usually only obtainable in a healthcare setting can now be available to patients in the comfort of their own home. Cardiologists can also access the real-time ECG results and offer their interpretation online. Without the inconvenience of getting an ECG only through a medical facility, both patients and healthcare workers can access this vital information in a timely, accurate and convenient manner.  “Overall, we hope to bring the home use 12-lead ECG to all the locations and situations that need one,” said Dr. Chang.

▲ECG QT converts the conventional ten electrodes to one simple pad. Not only can it reduce errors due to pad misalignment, but the patient can also choose the appropriate pad size (S-XL) for their body. A small wearable medical grade ECG device about the size of a deck of cards can be easily placed in a pocket (shown below).

After tackling problems associated with the conventional ECG, QT Medical has combined cloud, big data, artificial intelligence (AI), and physicians’ clinical judgment to enhance the subsequent machine learning and analysis. Hopefully, in the future, AI and the high predictive power of an ECG can assist physicians in their clinical management of patients.

▲QT Medical presents the QT ECG, which allows patients to learn to use a medical grade product from a user’s manual without professional assistance. Moreover, through a smartphone/tablet, test results can be uploaded to cloud storage enabling a clinician to offer a timely diagnosis online—realizing the promise of telemedicine.

Attending CES to Gain More Exposure

To gain market share in the multi-hundred billion dollar global cardiovascular disease market, QT Medial has contacted the medical establishment regarding potential cooperation. Their accurate clinical data has garnered attention form clinical research institutions and pharmaceutical manufacturers’ Contract Research Organization (CRO) for possible use in evaluating cardiac safety of new medications to prevent drug-induced arrhythmias and sudden death. The upcoming exhibit at CES will represent QT Medical’s first step toward gaining widespread attention. Ultimately, Dr. Chang’s overriding aim is to deliver the device to patients directly. In doing so, QT Medical has stayed true to their motto of providing comprehensive cardiac care to all people all the time.

Due to their unrelenting desire to develop a user-friendly cardiac monitor, Dr. Chang and former University of California, Irvine (UCI) Professor Pai Chou started working on a prototype eight years ago, and then jointly founded QT Medical 5 years ago in the United States. The company is now twenty-members strong with branches in both United States and Taiwan. The US team primarily focuses on clinical testing, while the Taiwanese team conducts technological research. Their team members include ex-MediaTek signal engineers, cloud engineers, cloud analysts, and researchers from the Department of Biomedical Engineering at National Yang-Ming University (Taiwan). QT Medical founder Dr. Chang has modestly pointed out that compared to most other US medical device startups, his team does not have the most prominent medical background. They nevertheless are all willing to relentlessly pursue their common ideal.

Next year, QT Medical plans to seek FDA approval for their pediatric medical devices and to widely promote newborn screening. The company intends to significantly reduce the number of sudden neonatal deaths—the main purpose of their business plan. Undoubtedly, we have arrived at a turning point for ECG development. The history of mankind’s struggle against heart diseases will be rewritten, and a new chapter for smart medical devices will be born.

▲A strong, talented QT Medical team that includes former MediaTek engineers, senior cloud engineers, and biomedical engineers.

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