TORONTO, ONTARIO – CardioComm Solutions, Inc. (“CardioComm” or the “Company”) (TSX VENTURE:EKG) a global medical provider of consumer heart monitoring and electrocardiogram (“ECG”) acquisition and management software solutions, has completed its response to the USA Food and Drug Administration (“FDA”) for additional information following the Company’s filing of its premarket notification 510(k), Class II medical device clearance application for the HeartCheck™ CardiBeat and GEMS™ Mobile Application.
The 510(k) application started its 90 day Substantive Review by the FDA on June 8, 2018. The FDA requested additional information from the Company regarding the device July 27, 2018, which stops the clock on the Substantive Review time line. The countdown of the 90 days will restart upon the FDA accepting the Company’s response to the requested additional information.
The FDA’s request for additional information required external and independent third party testing for electromagnetic and electrostatic discharge compatibility. The FDA also requested data confirming the device’s ability to record ECGs of equivalent clinical quality, as compared to ECGs recorded using conventional ECG electrode patches and ECG cables. CardioComm was provided a maximum of 180 days to reply to the FDA examiner. While the Company intended to respond to the FDA within 90 days, the requested testing and documentation through third parties did not allow a response to the FDA to be completed within this time frame. All device tests have now been passed and results compiled for the reply to the FDA. The Substantive Review clock will restart once the FDA receives and accepts the Company’s reply. Based on the FDA’s published timelines, the Company projects a possible completion of the 510(k) application review by the end of December 2018. The Company notes that the FDA has the ability to request more time to complete their review at the FDA’s discretion.
The HeartCheck™ CardiBeat is the second of several planned Bluetooth-enabled ECG recording devices to be marketed by the Company. The first was the Bluetooth HeartCheck™ECG PEN. As indicated in the Company’s May 22, 2018 press release, the GEMS™ Mobile Smartphone app will have compatibility with a number of different wireless ECG recording devices, including wireless 12 lead devices which will have direct applicability to remote patient monitoring and telemedicine markets.
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. Refer to the Company’s May 22, 2018 press release for further information respecting the initial FDA filing.