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CardioComm Solutions Expands ISO Clearance to Include Multiple Biosign Monitoring Device Integrations in Support of Remote Patient Monitoring Markets
New ISO 13485:2016 MDSAP scope paves the way to integration of novel and multiple bio sign mon...
About this update from Cardiocomm Solutions, Inc.
[{"type":"text","content":"CardioComm Solutions Expands ISO Clearance to Include Multiple Biosign Monitoring Device Integrations in Support of Remote Patient Monitoring MarketsNew ISO 13485:2016 MDSAP scope paves the way to integration of novel and multiple bio sign monitoring devices for broader patient monitoring solution sales to the consumer and Rx markets globallyToronto, Ontario--(Newsfile Corp. - February 9, 2021) - CardioComm Solutions, Inc. (TSXV: EKG) (\"CardioComm\" or the \"Company\"), a leading global provider of consumer heart monitoring and electrocardiogram (\"ECG\") acquisition and management software solutions, has received approval on an expanded ISO 13485:2016 (\"ISO\") certification in compliance with the Medical Device Single Audit Program (\"MDSAP\") for Canada and the United States, to include pulse oximetry (\"PO2\"), blood pressure (\"BP\"), weight and temperature in addition to ECG monitoring hardware and software solutions.As remote patient monitoring needs continue to grow so does a need for credible data to be collected from people outside of a hospital or medical office. \"The expansion of virtual health care is here to stay. Accordingly, many patients are using vital sign/bio sign devices at home for measurements of heart rate, temperature, blood pressure and oxygen saturation. Having easy to use accurate devices is a crucial part of safe virtual care. As an emergency physician I frequently see unnecessary ED visits and \"near misses\" at home due to inaccurate readings from many popular bio sign devices in current use,\" states Dr John Foote, Mount Sinai Hospital Director, Emergency Medicine/Family Medicine Residency Program, Assistant Professor, DFCM, The University of Toronto and a member of the Company's medical advisory committee. In addition to providing highly accurate consumer and outpatient ECG monitoring capabilities, the Company has been approached to develop solutions to ensure more traditional measurements are monitored with equal accuracy. To meet these requests, CardioComm's expanded ISO MDSAP certification scope will allow the Company to develop integrations with one or many devices that can each, or configured as a set of devices, monitor ECGs as well as any other bio signal of interest. Adding PO2, BP and temperature specifically will address 2021 new device integration and product development roadmap plan...