Powerful Medical
17. December 2021

Powerful Medical launches ‘PMcardio-1’ – a clinical trial under the new EU MDR

Powerful Medical launches the historically first medical device clinical trial under the new EU Medical Device Regulation in Slovakia in cooperation with two of Slovakia’s largest private health insurers, Union (Achmea B.V.) and Dôvera.

Powerful Medical, a deep-tech research company active in applying AI in medicine since 2017, has teamed up with the two largest private Slovak insurers, Union and Dôvera, to launch a breakthrough digital health clinical trial in the country, involving 60 general physician practices and over 1,400 patients.

Given its size and scope, it is one of the most significant digital health clinical trials ever carried out in Central Europe. Run under the supervision of Prof. Robert Hatala, MD, PhD. – Head of Cardiology at the Slovak Medical University and Head of the Arrhythmology Department at the National Institute of Cardiovascular Diseases in Slovakia and principal investigator in the study, the ‘PMcardio-1’ trial was officially approved by ŠUKL (the Slovak State Institute for Drug Control) and constituted the first clinical trial historically approved under the new EU Medical Device Regulation (MDR) in Slovakia.

The goal of the clinical trial is to investigate the extent to which PMcardio improves the management of cardiovascular patients in the primary care setting, providing more consistent and accurate referrals to specialized secondary care as well as indications of adequate diagnostic procedures in comparison to the current practice.

“Powerful Medical is a truly innovative MedTech company. Clinical trials represent a substantial part of our research activities, and we are proud to lead this breakthrough clinical trial for general practitioners. We believe that our AI-powered clinical device, PMcardio, has enormous potential to save lives, time, and expenses, as well as to ensure accurate diagnosis and adequate referrals to secondary care,” said Robert Herman, Co-Founder and Chief Medical Officer at Powerful Medical.

Powerful Medical

Powerful Medical leads one of the most important shifts in modern medicine by augmenting human-made clinical decisions with artificial intelligence. Our primary focus is on cardiovascular diseases, the world’s leading cause of death.
Powerful Medical leads one of the most important shifts in modern medicine by augmenting human-made clinical decisions with artificial intelligence. Our primary focus is on cardiovascular diseases, the world’s leading cause of death.
About PMcardio:

PMcardio is the market leader in AI-powered diagnostics, addressing the world’s leading cause of death – cardiovascular diseases. The innovative clinical assistant empowers healthcare professionals to detect up to 40 cardiovascular diseases. In the form of a smartphone application, the certified Class IIb medical device interprets any 12-lead ECG image in under 5 seconds to provide accurate diagnoses and individualized treatment recommendations tailored to each patient.

About Powerful Medical:

Established in 2017, Powerful Medical has embarked on a mission to revolutionize the diagnosis and treatment of cardiovascular diseases. We are a medical company backed by 28 world-class cardiologists and led by our expert Scientific Board with decades of experience in daily patient care, clinical research, and medical devices. The results of our research are implemented, developed, certified, and brought to market by our 50+ strong interdisciplinary team of physicians, data scientists, AI experts, software engineers, regulatory specialists, and commercial teams.

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