PMcardio receives FDA Breakthrough Device Designation — read the full story
Powerful Medical is redefining the landscape of medical diagnostics with its AI-driven solutions. The company’s certified PMcardio platform revolutionizes the way cardiovascular diseases are detected, offering rapid and accurate diagnostics that pave the way for timely and effective treatment.
PMcardio is CE-marked as class IIb medical device under EU MDR and only certified for marketing in the European Union and the United Kingdom. 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.
PMcardio is CE-marked as class IIb medical device under EU MDR and only certified for marketing in the European Union and the United Kingdom. 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.
