TORONTO, ONTARIO – CardioComm Solutions, Inc. (TSX VENTURE: EKG) (“CardioComm” or the “Company”), a global medical provider of consumer heart monitoring and medical electrocardiogram (“ECG”) acquisition and management software solutions, confirms the USA Food and Drug Administration (“FDA”) has reduced the scope of their request for additional information for the Company’s premarket notification 510(k), Class II medical device clearance application for the HeartCheck™ CardiBeat and GEMS™ Mobile Application.
CardioComm submitted its most recent 510(k) application to the FDA for Class II Medial device clearance on the HeartCheck™ CardiBeat as previously reported. The Company was then requested by the FDA to provide additional data that included clinical evaluations to confirm the device’s ability to record ECGs equivalent to those using conventional ECG electrode patches and ECG cables.
Subsequent to receiving the Company’s reply with additional data, the FDA provided guidance on two primary items. These were:
1) the Company no longer was required to support the request for extensive ECG electrode testing data; and,
2) additional data was requested related to Bluetooth wireless coexistence testing.
In compliance to the FDA’s directive, the Company has submitted a letter of revocation of their supplementary information submission which was accepted by the FDA on December 26, 2018. The Company will provide the FDA a restatement of their response for additional information to the FDA by January 23, 2019 without clinical ECG testing data and with the requested wireless coexistence data. The FDA will have 31 days to complete the 510(k) review following receipt of CardioComm’s restated submission.
The Company will provide updates on this and future 510(k) applications. 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.