CardioComm Solutions, Inc. (TSX-V: EKG) a leading global provider of consumer heart monitoring and electrocardiogram acquisition and management software solutions, confirms it has completed a request for additional information from the US Food and Drug Administration 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.

About CardioComm Solutions

CardioComm Solutions’ patented and proprietary technology is used in products for recording, viewing, analyzing and storing electrocardiograms for diagnosis and management of cardiac patients. Products are sold worldwide through a combination of an external distribution network and a North American-based sales team. CardioComm Solutions has earned the ISO 13485:2016 certification, is HIPAA compliant and holds clearances from the European Union (CE Mark), the USA (FDA) and Canada (Health Canada).