New 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 globally
- 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.
Toronto, Ontario–(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 plans for the Company including those to be used for COVID-19 related health monitoring.
Since securing its ISO MDSAP certification in 2018, CardioComm has assisted medical device makers to have access for the sale of their medical devices in Canada by placing non-MDSAP ISO-certified devices under the Company’s own MDSAP certification. This has resulted in CardioComm becoming a preferred importer, distributor and reseller of hospital and consumer ECG medical devices for organizations based outside of Canada who do not hold their own ISO certifications under the Canada mandated MDSAP designation. For organizations looking to sell into the US, while ISO under MDSAP is not required for sales into the USA, CardioComm’s Canadian/USA MDSAP certification is accepted by the FDA and removes the need for routine FDA inspections where the registered manufacturer, such as CardioComm, is located in Canada.
The Company will provide additional updates related to multiple bio signal monitoring device integrations and adding new capabilities to its remote patient monitoring technologies.
To learn more about CardioComm’s products and for further updates regarding HeartCheck™ ECG device integrations including those with multiple bio sign monitoring capabilities, please visit the Company’s websites at www.cardiocommsolutions.com and www.theheartcheck.com.
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