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.
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.
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About PMcardio
PMcardio is a CE-marked Class IIb AI medical device that interprets any 12-lead ECG — from a photo or a digital file — in seconds. It detects 50+ ECG findings, including occlusion myocardial infarction (OMI) — the acute coronary occlusions that conventional STEMI criteria miss in over half of cases. Its Queen of Hearts™ OMI model holds FDA Breakthrough Device Designation, and PMcardio is already used by 100,000+ clinicians who have analyzed more than 2.5 million ECGs.
About Powerful Medical
Powerful Medical is a medical-technology company using artificial intelligence to transform how cardiovascular disease — the world’s leading cause of death — is diagnosed. Founded in 2017, it built PMcardio, the world’s first AI medical device to detect acute coronary occlusion (OMI) from an ECG. Its research is published in the European Heart Journal – Digital Health and validated across 25+ clinical studies, and its Queen of Hearts™ model earned FDA Breakthrough Device Designation. To date, PMcardio has supported the detection of 120,000+ heart attacks across 150+ hospital deployments worldwide.
