CardioComm Solutions' HeartCheck Device Enters Final FDA Review Phase
January 29, 2019 at 09:02 am
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CardioComm Solutions, Inc. 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.
CardioComm Solutions, Inc. is a Canada-based company, which develops software, hardware and core laboratory reading services related to electrocardiogram (ECG) and ambulatory arrhythmia monitoring systems for medical and consumer markets globally. The Company's specialization is in the software engineering of computer based (ECG) management and reporting software. The software permits physician interpretations of ECGs and supports private and public payer fee-for-service billings. The Companyâs device connectivity and ECG management technologies are used in medical, consumer, clinical research and telemedicine solutions for the recording, transmission, viewing, analyzing, reporting and storage of electrocardiograms, for arrhythmia screening, diagnosis, and management of cardiac patients. Its Global ECG Management Solutions (GEMS) and GlobalCardio (Cloud based GEMS) products are licensed worldwide to hospitals, ECG commercial reading services and physicians.