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CardioComm Solutions $EKG Expands ISO Clearance to Include Multiple Biosign Monitoring Device Integrations in Support of Remote Patient Monitoring Markets $WELL.ca $PRN.ca $VMD.ca $VHI.ca

Posted by AGORACOM-JC at 8:28 AM on Tuesday, February 9th, 2021

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.

Read More: https://agoracom.com/ir/CardioCommSolutions/forums/discussion/topics/754966-cardiocomm-solutions-expands-iso-clearance-to-include-multiple-biosign-monitoring-device-integrations-in-support-of-remote-patient-monitoring-markets/messages/2302805#message

Cardiologists to Use the HeartCheck(TM) #CardiBeat With #ECG Triaging Services for Remote Patient ECG Monitoring – CardioComm Solutions $EKG.ca $ATE.ca $TLT.ca $OGI.ca $ACST.ca $IPA.ca

Posted by AGORACOM-JC at 7:25 AM on Monday, December 21st, 2020

Patient Self-Monitoring Extends Physicians’ Reach for Monitoring During COVID-19

  • Confirms the start of an out-of-office ECG monitoring program using the HeartCheck™ CardiBeat Handheld ECG monitor, the GEMS™ Mobile RPM Smartphone app and the SMART Monitoring ECG triaging service to support prescribed in-home arrhythmia monitoring.
  • Heart Health Institute, a large arrhythmia practice network located in the Greater Toronto Area, will be recommending the HeartCheck™ CardiBeat to their cardiac patients for up to six months of in-home, arrhythmia self-monitoring use with an emphasis on detecting a recurrence of atrial fibrillation and supraventricular tachycardia.

TORONTO, ON / December 20, 2020 / CardioComm Solutions, Inc. (TSXV:EKG) (“CardioComm” or the “Company“), a global provider of consumer heart monitoring and electrocardiogram (“ECG“) device and software solutions, confirms the start of an out-of-office ECG monitoring program using the HeartCheck™ CardiBeat Handheld ECG monitor, the GEMS™ Mobile RPM Smartphone app and the SMART Monitoring ECG triaging service to support prescribed in-home arrhythmia monitoring.

The Heart Health Institute (“HHI“), a large arrhythmia practice network located in the Greater Toronto Area (Ontario, Canada), will be recommending the HeartCheck™ CardiBeat to their cardiac patients for up to six months of in-home, arrhythmia self-monitoring use with an emphasis on detecting a recurrence of atrial fibrillation and supraventricular tachycardia.

CardioComm’s GEMS™ Mobile Smartphone app supports physician and research-based remote patient monitoring (“RPM“) requirements including providing rapid ECG reporting directly to the prescribing physician’s electronic medical records as patient triggered ECGs are taken. ECGs recorded by HHI patients using the GEMS™ Mobile RPM Smartphone app and the HeartCheck™ CardiBeat be rapidly triaged by CardioComm’s SMART Monitoring ECG service to detect for the presence of any number of arrhythmias. Any submitted ECG recordings that show a presence of a cardiac arrhythmia will be flagged so that HHI patients may be contacted and a follow-up visit scheduled. ECG reports generated through GEMS™ Mobile are eligible for medical service reimbursement in both Canada and the US.

Physicians at HHI intend to introduce the use of the HeartCheck™ ECG/arrhythmia monitoring technology to patients with difficult to capture arrhythmias and to reduce clinical workload in dealing with COVID-19 precautions. Due to COVID-19, patients are reluctant to visit their physician for cardiac testing and some pratices have also implemented new protocols that have made it more challenging to see their patients.

Under the GEMS™ Mobile RPM model, patients will be able to purchase the HeartCheck™ CardiBeat directly through the HHI offices or on-line directly from CardioComm with an HHI physician referral. ECG reporting will be made available at no cost to the patients over a six month monitoring period or until a diagnosis has been made. Following completion of the HHI monitoring period, patients will be able to continue to use the wireless HeartCheck™ CardiBeat ECG device and GEMS™ Mobile app under the Company’s consumer use model.

The GEMS™ Mobile RPM app is available in Android and Apple Smartphone compatible versions as a free downloadable app and allows users to generate ECG reports to show to their physician. The app also allows users to request their ECG to be reviewed by CardioComm’s SMART Monitoring ECG reading service where the user does not have direct connectivity to their treating physician.

To learn more about CardioComm’s products and for further updates regarding HeartCheck™ ECG device RPM use by healthcare professionals please visit the Company’s websites at www.cardiocommsolutions.com and www.theheartcheck.com.

About CardioComm Solutions

CardioComm Solutions’ patented and proprietary technology is used in products for recording, viewing, analyzing and storing electrocardiograms for diagnosis and management of cardiac patients. Products are sold worldwide through a combination of an external distribution network and a North American-based sales team. CardioComm Solutions has earned the ISO 13485:2016 MDSAP certification, is HIPAA compliant and holds clearances from the European Union (CE Mark), the USA (FDA) and Canada (Health Canada).

FOR FURTHER INFORMATION PLEASE CONTACT:

Etienne Grima, Chief Executive Officer
1-877-977-9425 x227
[email protected]
[email protected]

Forward-looking statements

This release may contain certain forward-looking statements and forward-looking information with respect to the financial condition, results of operations and business of CardioComm Solutions and certain of the plans and objectives of CardioComm Solutions with respect to these items. Such statements and information reflect management’s current beliefs and are based on information currently available to management. By their nature, forward-looking statements and forward-looking information involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future and there are many factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements and forward-looking information.

In evaluating these statements, readers should not place undue reliance on forward-looking statements and forward-looking information. The Company does not assume any obligation to update the forward-looking statements and forward-looking information contained in this release other than as required by applicable laws, including without limitation, Section 5.8(2) of National Instrument 51-102 (Continuous Disclosure Obligations).

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

SOURCE: CardioComm Solutions, Inc

Quebec Pharmacists Launch #ECG Screening for the Prevention of Drug Induced Sudden Cardiac Death – CardioComm Solutions $EKG.ca $ATE.ca $TLT.ca $OGI.ca $ACST.ca $IPA.ca

Posted by AGORACOM-JC at 11:04 AM on Thursday, December 17th, 2020

HeartCheck™ CardiBeat and SMART Monitoring ECG Triaging to be used in Screening Services for detection of QT Prolongation in Community Pharmacies

  • Confirms the start of a pharmacy-based ECG monitoring service to screen for prolonged QT interval for the prevention of drug induced sudden cardiac death.
  • Under the Company’s Allied Health Professional Partner Program, the HeartCheck™ CardiBeat and GEMS™ Mobile Smartphone app will be used to collect ECGs recorded by patients under the direction of a pharmacist.
  • Recorded ECGs will be passed from the GEMS™ Mobile app to the Company’s SMART Monitoring ECG reading service to be triaged.
  • All findings will be sent directly to the pharmacist and any submitted ECG recordings that show a presence of prolonged QT interval or any other cardiac arrhythmia will be flagged so that the pharmacist may then follow up as needed with the patient’s treating physician.

TORONTO, ON / December 17, 2020 / CardioComm Solutions, Inc. (TSXV:EKG) (“CardioComm” or the “Company“), a global provider of consumer heart monitoring and electrocardiogram (“ECG“) device and software solutions, confirms the start of a pharmacy-based ECG monitoring service to screen for prolonged QT interval for the prevention of drug induced sudden cardiac death.

Under the Company’s Allied Health Professional Partner Program, the HeartCheck™ CardiBeat and GEMS™ Mobile Smartphone app will be used to collect ECGs recorded by patients under the direction of a pharmacist. Recorded ECGs will be passed from the GEMS™ Mobile app to the Company’s SMART Monitoring ECG reading service to be triaged. All findings will be sent directly to the pharmacist and any submitted ECG recordings that show a presence of prolonged QT interval or any other cardiac arrhythmia will be flagged so that the pharmacist may then follow up as needed with the patient’s treating physician.

Pharmacists plan to run ECG tests on patients when picking up a prescription. All QT and QTc interval findings will be kept on file with the goal of recording QT measurements for any patient with known cardiac issues and starting any new medication known to influence the QT interval. “As polypharmacy analysis becomes more prevalent in a pharmacist’s daily tasks, the use of the HeartCheck™ CardiBeat device will allow staff to quickly measure the patient’s QT/QTc and make a clinical judgment as per the safety of the prescriptions being dispensed”, states pharmacist K. Manoukian.

QT interval prolongation is a recognized adverse drug reaction and risk factor for torsades de pointes (TdP), a fatal arrhythmia that can result in sudden cardiac death. While rare, the severity of TdP makes QT prolongation a serious concern when prescribing medications.

Pharmacists have a legal and professional responsibility to evaluate/mitigate medication adverse and serious adverse event risk factors and are the final decision makers in dispensing or not dispensing medications. The surface ECG is the only way to confirm or rule out the presence of a prolonged QT interval. The HeartCheck™ CardiBeat provides a useful tool as QT prolongation can now be easily, quickly and cost effectively obtained in community pharmacies and be compared to well established normal duration ranges. Without an ECG sudden cardiac death due to a prolonged QT interval may be the first and only evidence of the disease. Prior to the release of CardioComm’s ECG screening technologies, QT interval prolongation ECG screening was not available outside of the hospital setting.

Listings of medications known to cause TdP through acquired QT syndrome prolongation in healthy people (crediblemeds.org, sads.org.uk and heartcentre.ca) contain more than 100 common medications, many of which are dispensed by pharmacists. These include common antibiotics, medications to treat yeast infections, diuretics, anti-arrhythmia heart medications, and antidepressant and antipsychotic medications. Additionally, COVID-19 infection, a history of cardiac arrest and cardiovascular disease, age and women on heart medications are also known to increase the risk for cause acquired QT interval prolongation.

Through the screening service CardioComm will earn revenue from a per ECG QT interval triaging service fee. With the program now launched in Quebec, the Company will next look to the introduction of the QT interval ECG screening services in pharmacies and physician practices in other provinces.

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.

About CardioComm Solutions

CardioComm Solutions’ patented and proprietary technology is used in products for recording, viewing, analyzing and storing electrocardiograms for diagnosis and management of cardiac patients. Products are sold worldwide through a combination of an external distribution network and a North American-based sales team. CardioComm Solutions has earned the ISO 13485:2016 MDSAP certification, is HIPAA compliant and holds clearances from the European Union (CE Mark), the USA (FDA) and Canada (Health Canada).

FOR FURTHER INFORMATION PLEASE CONTACT:

Etienne Grima, Chief Executive Officer
1-877-977-9425 x227
[email protected]
[email protected]

Forward-looking statements

This release may contain certain forward-looking statements and forward-looking information with respect to the financial condition, results of operations and business of CardioComm Solutions and certain of the plans and objectives of CardioComm Solutions with respect to these items. Such statements and information reflect management’s current beliefs and are based on information currently available to management. By their nature, forward-looking statements and forward-looking information involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future and there are many factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements and forward-looking information.

In evaluating these statements, readers should not place undue reliance on forward-looking statements and forward-looking information. The Company does not assume any obligation to update the forward-looking statements and forward-looking information contained in this release other than as required by applicable laws, including without limitation, Section 5.8(2) of National Instrument 51-102 (Continuous Disclosure Obligations).

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

SOURCE: CardioComm Solutions, Inc.

CardioComm Solutions $EKG.ca to Bring #ECG Monitoring to Remote Patient and #COVID-19 Monitoring Platforms $ATE.ca $TLT.ca $OGI.ca $ACST.ca $IPA.ca

Posted by AGORACOM-JC at 8:38 PM on Tuesday, December 15th, 2020
  • Entered into a technology integration agreement with LiveCare Corp. and a Value-Added Reseller and Distribution Agreement with Alliance Tele-Med, to provide integrated ECG monitoring through the LiveCare Link+ device and telemedicine platform.
  • CardioComm confirms integration of their FDA and Health Canada cleared GEMS™ ECG management software, the wireless HeartCheck™ CardiBeat ECG monitor and access to the SMART Monitoring ECG reading service into the Link+ platform has been completed.
  • Under the agreement, the GEMS™ Mobile app technology was embedded into the Link+ gateway device allowing ECGs to be transferred through the Link+ platform to the CardioComm SMART Monitoring ECG reading service.
  • Once an ECG report is completed, the report findings are then securely transmitted to the Link+ platform and from there to the Link+ platform’s remote patient monitoring teams.

TORONTO, ON / December 15, 2020 / CardioComm Solutions, Inc. (TSXV:EKG) (“CardioComm” or the “Company“), a global provider of consumer heart monitoring and electrocardiogram (“ECG“) device and software solutions, is pleased to confirm it has entered into a technology integration agreement with LiveCare Corp. (“LiveCare“) and a Value-Added Reseller and Distribution Agreement with Alliance Tele-Med (“Alliance“), to provide integrated ECG monitoring through the LiveCare Link+ device and telemedicine platform.

CardioComm confirms integration of their FDA and Health Canada cleared GEMS™ ECG management software, the wireless HeartCheck™ CardiBeat ECG monitor and access to the SMART Monitoring ECG reading service into the Link+ platform has been completed. Under the agreement, the GEMS™ Mobile app technology was embedded into the Link+ gateway device allowing ECGs to be transferred through the Link+ platform to the CardioComm SMART Monitoring ECG reading service. Once an ECG report is completed, the report findings are then securely transmitted to the Link+ platform and from there to the Link+ platform’s remote patient monitoring teams.

Link+ is a patented smart home gateway that integrates multiple key medical bio-sign monitoring devices in a patient’s home through a proprietary, touch-free device which is always connected to the 4G network. There is no need for patients to connect to any specific Wi-Fi network for the Link+ to fully operate and, once activated, the Link+ transmits data directly to LiveCare’s HIPAA compliant cloud. The Link+ is fully reimbursable through Medicare, Medicaid and many commercial insurance plans using multiple CPT codes.

Through the addition of the GEMS™ technology into the Link+ gateway device, the Link+ device will be capable of recognizing multiple ECG devices with up to 12 leads of ECG recording and provide Link+ customers with more options in choosing a device of their preference. The HeartCheck™ CardiBeat will be the recommended device for remote ECG patient monitoring given its availability in Canada, the US and Europe. All recorded ECGs will be passed through CardioComm’s SMART Monitoring ECG triaging service. ECG reports confirming the presence or absence of an arrhythmia will be provided to Link+ users.

The Link+ platform with ECG monitoring sales and marketing will be undertaken exclusively by Alliance with a focus on monitoring patients with or suspected to have COVID-19. Sales into the US is where the primary marketing efforts are targeted for 2021. CardioComm will see revenue from the sales of the HeartCheck™ CardiBeat ECG devices as well as from ECG triaging service fees.

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.

About CardioComm Solutions

CardioComm Solutions’ patented and proprietary technology is used in products for recording, viewing, analyzing and storing electrocardiograms for diagnosis and management of cardiac patients. Products are sold worldwide through a combination of an external distribution network and a North American-based sales team. CardioComm Solutions has earned the ISO 13485:2016 MDSAP certification, is HIPAA compliant and holds clearances from the European Union (CE Mark), the USA (FDA) and Canada (Health Canada).

About LiveCare (www.livecareusa.com)

LiveCare’s mission is to improve patient outcomes, lower healthcare costs, and reduce hospital readmissions by developing technology to assist patients and providers during the critical transitional care period. LiveCare’s technology improves patient compliance with post-discharge medical protocols and enhances engagement between patients and providers. With a team of experienced professionals working in research and development, sales, and other capacities, LiveCare is putting the needs of patients and providers at the forefront as it moves the RPM market forward from its corporate headquarters in New York City.

About Alliance-Telemed, LLC

Alliance Tele-Med is a US-based Value-Added Wholesaler & Reseller of state-of-the-art remote patient monitoring (RPM) technology and care management services solutions for domestic and international healthcare delivery organizations and their patients. The company engages with healthcare and life sciences organizations such as Independent and Hospital-Owned Medical Practices, Independent Hospitals and Health Systems, Accountable Care Organizations (ACO’S), Independent Physician Associations (IPA’s), Provider Networks, large Employer Groups and Third Party Administrators, Clinics, FQHC and Regional Health Centers, Senior ‘Aging in Place’ Companies and Facilities such as Assisted Living Facilities, Nursing Homes, Skilled Nursing Facilities, Home Health Companies, pharmaceutical companies, and Clinical Research Organizations (CRO’s).

FOR FURTHER INFORMATION PLEASE CONTACT:

Etienne Grima, Chief Executive Officer
1-877-977-9425 x227
[email protected]
[email protected]

Forward-looking statements

This release may contain certain forward-looking statements and forward-looking information with respect to the financial condition, results of operations and business of CardioComm Solutions and certain of the plans and objectives of CardioComm Solutions with respect to these items. Such statements and information reflect management’s current beliefs and are based on information currently available to management. By their nature, forward-looking statements and forward-looking information involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future and there are many factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements and forward-looking information.

In evaluating these statements, readers should not place undue reliance on forward-looking statements and forward-looking information. The Company does not assume any obligation to update the forward-looking statements and forward-looking information contained in this release other than as required by applicable laws, including without limitation, Section 5.8(2) of National Instrument 51-102 (Continuous Disclosure Obligations).

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.