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

BRATISLAVA, Slovakia, Jan. 03, 2022 (GLOBE NEWSWIRE) — 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 1400 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, Ph.D. – Head of Cardiology at the Slovak Medical University and Head of Arrhythmia 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 constitutes 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 the PMcardio clinical assistant 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 assistant, 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.

PMcardio, Powerful Medical’s flagship product, is an AI-powered clinical assistant that allows healthcare professionals to interpret electrocardiograms (ECGs) with the confidence of an expert cardiologist. It is a Class II(b) medical device under the EU MDR regulation.

The product integrates cutting-edge AI technology into a simple mobile application, usable on any smartphone. Its accessibility can significantly disrupt cardiac care even on the primary care level, as it provides general practitioners and other healthcare professionals with the diagnostic capabilities of an AI trained on millions of previous cases. Earlier and more accurate diagnostics of cardiovascular diseases present an enormous potential to save lives and drastically reduce healthcare costs.

Powerful Medical is a deep-tech research company utilizing cutting-edge technology to solve some of the biggest challenges in modern medicine. The company focuses on increasing the standard of patient care by applying machine learning and AI, combining the latest technological advancements and research with solid business fundamentals. Powerful Medical is using millions of historical data points to deliver groundbreaking insights and tools, such as patient outcome predictions, precise automated diagnostics, patient-specific treatment recommendations and much more.

Media contact:
E-mail: media@powerfulmedical.com
Website: https://www.powerfulmedical.com/