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.
