TORONTO, ONTARIO – CardioComm Solutions, Inc. (TSX VENTURE: EKG) (“CardioComm” or the “Company”), a leading global medical provider of consumer heart monitoring and electrocardiogram (“ECG”) acquisition and management software solutions, confirms it has completed a request for additional information from the US Food and Drug Administration (“FDA”) for the Company’s premarket notification 510(k), Class II medical device clearance application for the HeartCheck™ CardiBeat and GEMS™ Mobile Application.
The Company had submitted a letter of revocation of their supplementary information submission on December 26, 2018 in compliance with the FDA’s directive. The Company has now provided the FDA a restatement of their response for additional information as of January 23, 2019, which the FDA has confirmed received. The FDA will now have 31 days to complete the 510(k) review of CardioComm’s restated submission.
To learn more about CardioComm’s products and for further updates regarding HeartCheck™ ECG device integrations please visit the Company’s websites at www.cardiocommsolutions.com and www.theheartcheck.com.