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QT Medical Receives U.S. FDA 510(k) Clearance for Home-use 12-lead ECG


QT Medical aims to bridge the gap between patients and healthcare providers using their cloud-based 12-lead ECG system to bring high quality cardiac care to homes.

Los Angeles, CA — May 4, 2018  QT Medical, Inc. received U.S. FDA 510(k) clearance for its revolutionary “QT ECG”, a 12-lead electrocardiogram (ECG) system that can be used in the home and operated by the patient themselves to perform a hospital-grade ECG scan of their hearts that is instantaneously sent through the cloud to a physician for evaluation.

QT Medical’s technology empowers the patients to take an active role in managing their heart disease. Heart disease is responsible for 1 out of every 4 deaths in the U.S. and is the No. 1 killer world-wide. No longer do patients with heart disease have to make long trips to their cardiologists, hospitals, or emergency rooms to get diagnostic, hospital-grade ECG scans. They can now perform these tests from the comfort of their homes or anywhere with a smartphone or tablet connection, allowing peace of mind, saving time, reducing stress and improving outcomes.

From the doctor’s perspective, QT Medical’s technology enables them to provide better and timely care to their patients. The QT ECG opens a window for the doctors to have the full cardiac diagnostic information they need at their fingertips to make an informed medical decision for their patients. Comparing to the time it takes for the patient to call for an ambulance or rush to the emergency room, QT ECG delivers crucial ECG data to doctors wherever they may be, allowing immediate diagnosis and saving precious time in determining proper management during a potential cardiac event.

QT Medical’s ECG is a health insurance company’s magic bullet when aiming to reduce costs for patients recovering from acute cardiac care. Patients who are discharged from a hospital following coronary artery bypass surgery or placement of a coronary stent may not know whether they should return to the emergency room if they experience chest discomfort. The QT ECG connects patients with their cardiologists in almost real time. When patients have symptoms, they can quickly and easily send their ECG to the cloud for diagnosis, potentially avoiding costly, time-consuming and unnecessary visits to the emergency room. Importantly, when the home ECG shows significant changes, the cardiologist can make the diagnosis immediately and expedite the process to ensure the patient receives timely and immediate care.

“ECG is the most commonly used test for the heart, but until now it was only available in hospitals and doctor’s offices.” said Dr. Ruey-Kang Chang, CEO of QT Medical. “When patients are empowered with the tools they need, they can take care of their disease much better. Therefore, it is our mission to bring 12-lead ECG to the homes of millions of patients.” Dr. Chang added: “In clinical trials, we proved that QT ECG can be used by patients with no training, and the results at home with QT ECG are of the same high-quality as those performed in the hospital by a technician using a much larger and costlier ECG machine.”

“We are thrilled that the hard work here done at LA BioMed by Dr. Chang and his colleagues is coming to fruition. The development of a home-use, simple and inexpensive ECG device will save hundreds, if not thousands of lives, when adopted nationwide and beyond” said LA BioMed President and CEO Dr. David Meyer. “The concept, the development and now the device were conceived locally and will bring needed recognition to biomedical research and more jobs to Los Angeles County”.

About QT ECG

QT ECG is hospital-quality, medical standard 12-lead ECG that can be operated by patients at home with no need for training. The QT ECG system includes a super-compact ECG recorder, a proprietary pre-positioned electrode strip that comes in 4 sizes for adults, apps for iOS and Android phones and tablets, and HIPAA-compliant cloud.

About QT Medical

QT Medical, Inc. is a company specializing in cloud-connected cardiac monitoring devices and services based in Los Angeles, CA. Incorporated in 2013, QT Medical’s technology was spun off from research conducted at Los Angeles Biomedical Research Institute by its founder and CEO, Dr. Ruey-Kang Chang. Dr Chang is a practicing pediatric cardiologist with over 20 years of experience and has an appointment as Professor of Pediatrics at the David Geffen School of Medicine at UCLA.

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