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QT Medical announces that it has received Health Canada’s Medical Device License (MDL) registration, marking a milestone in the company’s global expansion
LOS ANGELES, CA, UNITED STATES, March 5, 2025 /EINPresswire.com/ -- QT Medical, a leader in innovative ECG solutions, proudly announces that its flagship product, PCA 500, has received Health Canada registration, marking a significant milestone in the company’s global expansion. With regulatory approvals from the FDA (USA), CE Mark (Europe), PMDA (Japan), TGA (Australia), and now Health Canada, PCA 500 is poised to revolutionize ECG diagnostics in the Canadian healthcare market.
Designed for both professional and personal use, PCA 500 is a compact, digital, and wireless 12-lead ECG system that simplifies traditional ECG procedures while reducing errors in electrode placement. It is the only medical-standard 12-lead ECG cleared for both professional and layperson (patient) use. Featuring a prepositioned electrode system and cloud-based ECG management, PCA 500 delivers an efficient, accurate, and user-friendly solution for cardiac diagnostics and monitoring outside of traditional hospital settings.
Since its U.S. launch in 2019, PCA 500 has demonstrated its versatility and reliability across a broad range of applications, including remote diagnostics (airlines, super yachts), clinical trials, telehealth, student-athlete screenings, correctional facilities, EMS, clinics, hospitals, and thousands of home-based patients.
“We are thrilled to bring PCA 500 to Canada,” said Dr. Ruey-Kang Chang, CEO of QT Medical. “With the increasing demand for telemedicine, remote diagnostics, and at-home monitoring, PCA 500 is set to transform how ECGs are conducted in Canada, significantly improving accessibility and efficiency in cardiac care.”
With its regulatory approval in Canada, QT Medical is expanding its presence in the country and aims to make PCA 500 accessible to healthcare providers nationwide. The company welcomes collaborations with Canadian medical device distributors to support market entry and distribution.
About QT Medical:
QT Medical is a pioneering medical technology company dedicated to advancing ECG solutions for healthcare, telemedicine and home-based care. By combining cutting-edge technology with an intuitive design, QT Medical’s products, including the PCA 500, provide superior cardiac diagnostics and monitoring with ease of use for both healthcare professionals and patients. With regulatory approvals in multiple countries, QT Medical is committed to expanding access to high-quality cardiac diagnostics worldwide. For more information , visit https://www.qtmedical.com
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