Frequently Asked Questions
What is PMcardio?
PMcardio is an AI-powered smartphone application that empowers healthcare professionals to interpret ECGs in just a few seconds and accurately diagnose 39 heart conditions. Based on patient data, the platform also recommends further treatment and management of the patient according to the latest clinical practice guidelines. Furthermore, your staff can use PMcardio to convert paper ECGs into a digital format for convenient storage, retrieval, and exchange of data. PMcardio is a CE-marked Class IIb medical device that is easily accessible through any smartphone and is compatible with any 12-lead ECG device.
Who is PMcardio intended for?
Any healthcare provider who interprets ECGs and treats heart diseases will benefit from PMcardio. Powered by AI, PMcardio enables healthcare professionals to accurately diagnose 39 heart conditions, make faster and more confident decisions regarding patients’ treatment and refer them correctly to further care.
To use PMcardio, all you need is a smartphone and an internet connection, making it easy to incorporate into various settings, such as:
• GP practices
• Hospitals
• Emergency responders
• Telemedicine providers
Medical Disclaimer: PMcardio is classified as a medical device and should only be used by healthcare providers in a clinical setting.
How do I know the application provides reliable diagnoses? How was it validated?
The PMcardio diagnostic module was trained on a dataset of almost 1 million standard 12-lead ECGs from 172,750 patients to detect 39 individual diagnoses of heart rhythms, heart blocks, infarctions, hypertrophies, and ectopies.
PMcardio was benchmarked against clinicians and has demonstrated an average of 38.18% improved detection of all 39 tested ECG diagnoses compared to general practitioners and achieved non-inferior performance to cardiologists.
PMcardio was developed under the close guidance and advice of world-renowned cardiologists and specialists. Based on studies, PMcardio has outperformed clinical algorithms and experienced physicians in every aspect.
Learn more about the results of PMcardio’s clinical validation here.
Why should hospitals use PMcardio?
PMcardio enables healthcare professionals to digitize, store, and exchange ECG reports, patient data, treatment plans, and other patient records while being compliant with all privacy regulations. All patient data and digitized ECGs can be securely transferred within the PMcardio application to any hospital database or patient management system.
PMcardio is device-neutral and compatible with any hospital workflow and technical setup. You can incorporate PMcardio on top of your existing hospital infrastructure, as it is available to any healthcare professional with a smartphone, reducing the need to purchase any additional hardware and saving costs.
Since PMcardio enables physicians to interpret ECGs and diagnose heart conditions faster, the application saves valuable time and resources for your clinic.
Which diseases does PMcardio help detect and treat?
PMcardio can interpret ECGs and detect 39 different heart conditions and 12 measurements, including different arrhythmias, heart blocks, infarctions, ectopies, and other heart abnormalities.
How is the company and the product certified and regulated?
Powerful Medical is a medical device manufacturer certified to design, develop, and distribute Software as a Medical Device (SaMD) to diagnose and treat diseases using AI technology. Our company and products are regulated under the European Union Medical Device Regulation (MDR) 2017/745.
We have established a Quality Management System according to ISO 13485:2016, an international quality standard that regulates the design and production of medical devices. Our QMS is also compliant with 21 CFR 820, which outlines the requirements that all medical device manufacturers in the United States must follow.
PMcardio is also certified as a Class IIb medical device by TÜV SÜD Product Service GmbH. As such, it can be officially marketed in the European Union and used as a medical device in a clinical environment. Compared to lower-risk Class IIa medical devices, Class IIb devices are subject to more rigorous testing and validation.
In addition to the EU MDR certification, our products are currently pending FDA approval, enabling PMcardio to expand to the US.
Note: PMcardio technology has not yet been cleared by the US Food and Drug Administration (FDA) for marketing in the USA. Not all modules of the PMcardio platform may be available in your region. Prior to use, reference the Instructions for Use, for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.
How does the AI technology work?
Our AI technology performs two main processes: Digitization and diagnostics. Firstly, our AI combines case-specific algorithms with current technologies, such as Image Recognition, to extract signals from paper ECGs and convert them into a digital format.
Secondly, PMcardio can diagnose 39 cardiovascular diseases. Our AI is developed by experienced AI architects who work hand-in-hand with world-class cardiologists and specialists. Throughout the process, it was rigorously trained on millions of previous cases. Our board of cardiologists and medical authorities have validated all outcomes to ensure accuracy.
Our uniquely-trained AI technology utilizes Machine Learning algorithms to make a diagnosis based on the ECG results and patient information provided by healthcare professionals.
