TORONTO, ONTARIO – CardioComm Solutions, Inc. (“CardioComm” or the “Company”) (TSX VENTURE:EKG) a leading global provider of consumer heart monitoring and electrocardiogram (“ECG”) acquisition and management software solutions, has received a request for additional information from the USA Food and Drug Administration (“FDA”) 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.
While CardioComm will have 180 days to provide a reply to the FDA examiner, the Company intends to respond within a much shorter time period of 90 days. The requests for additional information were expected as a result of recent changes that have been made to the medical device clearance review process, especially with respect to personal information protection and electronic data access (PIPEDA) and data security standards.
The HeartCheck™ CardiBeat will also be branded as the HeartCheck™ Beat. The Bluetooth enabled and rechargeable handheld device will allow for a medical grade ECG recording to be taken simply by holding the device in both hands (a Lead I ECG recording), or for a Lead II ECG to be recorded when held in the right hand and against the left side of the chest. Lead II measurements are more accurate and clinically preferred by physicians for recording and diagnosing arrhythmias such as atrial fibrillation, and this represents a significant diagnostic advantage over other currently available devices.
The FDA premarket notification 510(k) application included CardioComm’s iOS/Android compatible GEMS™ Mobile App. GEMS™ Mobile is based directly on the Company’s Global ECG Management Solutions (GEMS™) software. As indicated in the Company’s May 22, 2018 press release, GEMS™ Mobile will have compatibility with a number of different wireless ECG recording devices, including the option to support wireless 12 lead devices. Future 510K applications will be registered as the company continues to identify and integrate new ECG devices compatible with the same GEMS™ Mobile application contained in the current 510(k) filing.
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. See the Company’s May 22, 2018 press release for further information regarding the initial FDA filing.
