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CardioComm Solutions $EKG.ca Files with Health Canada for Direct to Consumer Sales Approval of the Heartcheck(TM) Cardibeat Handheld ECG Device $ATE.ca $TLT.ca $OGI.ca $ACST.ca $IPA.ca

Posted by AGORACOM-JC at 9:21 AM on Tuesday, April 9th, 2019


  • Filed with Health Canada for approval for the over-the-counter sales and marketing of their GEMS™ Mobile smartphone app and their newest handheld, heart rhythm monitor, the HeartCheck™ CardiBeat.
  • Both were cleared by the Food and Drug Administration in early 2019 and are available for sale direct to consumers in the US.

Bluetooth Connected HeartCheck CardiBeat and GEMS Mobile Smartphone App to Target Underserviced Canadian Home and Telemedicine Arrhythmia Monitoring Markets

Toronto, Ontario–(April 9, 2019) – CardioComm Solutions, Inc. (TSXV: EKG) (“CardioComm” or the “Company“), a global provider of consumer heart monitoring and electrocardiogram (“ECG“) acquisition and management software solutions, has filed with Health Canada for approval for the over-the-counter (“OTC“) sales and marketing of their GEMS™ Mobile smartphone app and their newest handheld, heart rhythm monitor, the HeartCheck™ CardiBeat. Both were cleared by the Food and Drug Administration (“FDA“) in early 2019 and are available for sale direct to consumers in the US.

The Bluetooth enabled and rechargeable CardiBeat allows a medical grade ECG recording to be taken by holding the device in both hands or by holding the device in the right hand and against the left side of the chest. The GEMS™ Mobile smartphone app is a slimmed down version of the Company’s hospital-based Global ECG Management System (“GEMS™”) software, which is separately cleared by Health Canada and licensed by 19 Canadian Hospitals.

GEMS™ Mobile manages ECGs recorded by HeartCheck™ devices and provides near-real-time feedback through the generation of an ECG report which can be shared with a physician. For those looking for feedback on their ECGs, GEMS™ Mobile provides access to CardioComm’s SMART Monitoring ECG reading service for a professional review for the presence of a number of potential arrhythmias in under an hour. ECGs can also be connected directly to the GEMS™ WIN software allowing patients to be monitored directly by hospitals and healthcare professionals.

Unlike the US market, availability of personal ECG monitoring devices in Canada is limited due to ISO 13485 requirements that went into effect in 2019. Companies intending to sell medical devices into Canada must hold ISO 13485 certification in compliance with a more demanding Medical Device Single Audit Program (“MDSAP“). CardioComm completed its MDSAP certification in 2018 thereby solidifying the Company’s abilities to produce and sell its GEMS™ software and act as a preferred importer, distributor and reseller of hospital and consumer ECG medical devices.

GEMS™ Mobile is available on Apple’s App Store and on Google Play and is free with the purchase of a HeartCheck™ ECG device.

To learn more about CardioComm’s products please see the Company’s websites at www.theheartcheck.com and www.cardiocommsolutions.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 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.

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Posted in CardioComm Solutions | Comments Off on CardioComm Solutions $EKG.ca Files with Health Canada for Direct to Consumer Sales Approval of the Heartcheck(TM) Cardibeat Handheld ECG Device $ATE.ca $TLT.ca $OGI.ca $ACST.ca $IPA.ca

CLIENT FEATURE: CardioComm Solutions $EKG.ca – Connecting Your Heart To The Cloud $ATE.ca $TLT.ca $OGI.ca $ACST.ca $IPA.ca

Posted by AGORACOM-JC at 3:45 PM on Tuesday, March 26th, 2019

Global Leaders in Mobile  ECG Connectivity

  • 20 years of medical credibility licensing technologies to hospitals, physicians, remote patient monitoring  platforms, research groups and commercial call centers
  • Sold into > 20 countries, with the largest customer base located in the US
  • Class II medical device clearances and device agnostic for collecting, viewing, recording, analyzing and  storing of ECGs for management of patient and consumer health
  • ECG solutions for both consumer (OTC) and medical (Rx) markets
  • Owns all IP and source code
  • Market expert contributor for reports in m‐health, mobile cardiac monitoring and new advances in  consumer health and wellness monitoring

Recent Highlights

CardioComm Solutions Launches New GEM(TM) Mobile Universal ECG App Expanding ECG Reporting Services Across Global Markets Read More

  • Announced the release of a new version of the Company’s recently cleared US Food and Drug Administration (“FDA“) GEMS™ Mobile ECG app.
  • The new version is branded as the GEMS™ Universal ECG (“GEMS™ Universal“) and is capable of connecting with multiple manufacturer’s consumer and prescription ECG devices sold globally.

CardioComm Solutions Leverages the GEMS(TM) Mobile ECG App to Bring a Third FDA Cleared HeartCheck(TM) Branded ECG Device to the US Consumer Markets Read More

  • Confirms the start of an OEM co-marketing agreement for the HeartCheck™ Palm handheld ECG device, the Company’s newest GEMS™ Mobile ECG app (“GEMSTM Mobile“) enabled ECG device.
  • HeartCheck™ Palm will be the Company’s third US Food and Drug Administration (“FDA“) cleared HeartCheck™ branded handheld ECG device for over-the-counter (“OTC”) sales.

WATCH OUR RECENT INTERVIEW

 FULL DISCLOSURE: CardioComm Solutions Inc. is an advertising client of AGORA Internet Relations Corp.

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Posted in AGORACOM Client Feature, All Recent Posts, CardioComm Solutions | Comments Off on CLIENT FEATURE: CardioComm Solutions $EKG.ca – Connecting Your Heart To The Cloud $ATE.ca $TLT.ca $OGI.ca $ACST.ca $IPA.ca

CardioComm Solutions $EKG.ca Launches New GEM(TM) Mobile Universal ECG App Expanding ECG Reporting Services Across Global Markets $ATE.ca $TLT.ca $OGI.ca $ACST.ca $IPA.ca

Posted by AGORACOM-JC at 8:46 AM on Monday, March 25th, 2019

FDA Approval of New Version of GEMS Mobile ECG App Will Result in Growing Number of Partnerships with ECG Device Manufacturers

  • Announced the release of a new version of the Company’s recently cleared US Food and Drug Administration GEMS™ Mobile ECG app
  • New version is branded as the GEMS™ Universal ECG and is capable of connecting with multiple manufacturer’s consumer and prescription ECG devices sold globally

Toronto, Ontario–(March 25, 2019) – 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, announces the release of a new version of the Company’s recently cleared US Food and Drug Administration (“FDA“) GEMS™ Mobile ECG app. The new version is branded as the GEMS™ Universal ECG (“GEMS™ Universal“) and is capable of connecting with multiple manufacturer’s consumer and prescription ECG devices sold globally.

The GEMS™ Universal ECG app allows users access to CardioComm’s fee-for-use SMART Monitoring ECG reading service, through which they can request a review of their ECG(s) to confirm the presence or absence of arrhythmias. GEMS™ Universal will be available for a fee of $6 per month, which will include one free ECG triage. GEMS Universal will also be available under an annual fee of $69, with 12 free triage reports included. These reports may be requested at any time during a renewable one year subscription. CardioComm device partners will share in revenues generated from downloads of the app and from SMART Monitoring ECG readings.

GEMS™ Universal is a slimmed-down version of the Company’s Health Canada-approved, FDA-cleared and CE Mark-certified, hospital-based Global ECG Management System (GEMSTM). GEMS™ Universal will be marketed for use with non-HeartCheck™ branded ECG devices, and will allow users the ability to generate unlimited, medical-grade ECG PDFs in near-real-time.

The first release of the GEMS™ Universal ECG is compatible with several OEM and private label devices, including those manufactured by Contec Medical Systems and BORSAM Biomedical Instruments. These manufacturers provide CardioComm with access to a global audience of ECG device users in regions where other companies have already established hardware sales.

The GEMS™ ECG Universal ECG app is scheduled to be available on the App Store and Google Play in April.

For further updates regarding GEMSTM Mobile ECG device partnerships please see the Company’s websites at www.theheartcheck.com and www.cardiocommsolutions.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 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.

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Posted in CardioComm Solutions | Comments Off on CardioComm Solutions $EKG.ca Launches New GEM(TM) Mobile Universal ECG App Expanding ECG Reporting Services Across Global Markets $ATE.ca $TLT.ca $OGI.ca $ACST.ca $IPA.ca

CardioComm Solutions $EKG.ca Leverages the GEMS(TM) Mobile ECG App to Bring a Third FDA Cleared HeartCheck(TM) Branded ECG Device to the US Consumer Markets $ATE.ca $TLT.ca $OGI.ca $ACST.ca $IPA.ca

Posted by AGORACOM-JC at 8:43 AM on Thursday, March 21st, 2019


  • Confirms the start of an OEM co-marketing agreement for the HeartCheck™ Palm handheld ECG device, the Company’s newest GEMS™ Mobile ECG app (“GEMSTM Mobile“) enabled ECG device
  • The HeartCheck™ Palm will be the Company’s third US Food and Drug Administration (“FDA“) cleared HeartCheck™ branded handheld ECG device for over-the-counter (“OTC”) sales.

ECG Device Manufacturer Partnerships Grow as FDA Cleared GEMS(TM) Mobile Smartphone ECG App Expands Device Access to Consumer and Telemedicine Cardiac Monitoring Solutions

Toronto, Ontario–(March 21, 2019) – 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, confirms the start of an OEM co-marketing agreement for the HeartCheck™ Palm handheld ECG device, the Company’s newest GEMS™ Mobile ECG app (“GEMSTM Mobile“) enabled ECG device. The HeartCheck™ Palm will be the Company’s third US Food and Drug Administration (“FDA“) cleared HeartCheck™ branded handheld ECG device for over-the-counter (“OTC”) sales.

The HeartCheckTM Palm has a colour display and can record and save medical grade ECGs of 10 to 30 seconds in duration which are controlled through GEMSTM Mobile. Saved ECGs can be reviewed on the device and then transferred to a Smartphone. The ECG trace colour will change from red, to yellow, to green, to confirm the ECG recording quality. Recording time starts once the ECG waveform is green.

GEMSTM Mobile is a slimmed down version of the Company’s hospital-based Global ECG Management System (GEMSTM) software and holds a unique market position as the only FDA cleared ECG management Smartphone app that supports multiple manufacturers’ ECG monitoring devices.

GEMS™ Mobile provides HeartCheck™ ECG device users the ability to generate free, medical-grade ECG PDFs in near-real-time. GEMS™ Mobile users also have access to CardioComm’s SMART Monitoring ECG reading service through which they can request a professional review of their ECG to confirm the presence or absence of arrhythmias.

CardioComm will continue to develop ECG device manufacturer partnerships to expand the medical usability of these third party devices and to bring cost effective, innovative and credible cardiac monitoring solutions to the remote patient monitoring, consumer and clinical trials markets. CardioComm acknowledges the cooperation of Contec Medical Systems and BORSAM Biomedical Instruments as the original device manufacturers of the HeartCheck™ Palm and HeartCheck™ CardiBeat respectively.

GEMS™ Mobile is now available on the App Store and Google Play. The Company is pleased to announce that it has already received expressions of interest in the new devices from several prospective customers.

To learn about pre-orders for the HeartCheck™ device with free ECG reviewing packages included and for further updates regarding GEMSTM Mobile ECG device partnerships please see the Company’s websites at www.theheartcheck.com and www.cardiocommsolutions.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 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.

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Posted in All Recent Posts, CardioComm Solutions | Comments Off on CardioComm Solutions $EKG.ca Leverages the GEMS(TM) Mobile ECG App to Bring a Third FDA Cleared HeartCheck(TM) Branded ECG Device to the US Consumer Markets $ATE.ca $TLT.ca $OGI.ca $ACST.ca $IPA.ca

CardioComm Solutions $EKG.ca Releases Remote 12-lead ECG Telemed Solution with Arrythmia Detection and ECG Reading Services $ATE.ca $TLT.ca $OGI.ca $ACST.ca $IPA.ca

Posted by AGORACOM-JC at 8:39 AM on Thursday, March 14th, 2019

GlobalCardio 12 FLEX Supports Traditional 12-Lead ECG Devices and New Wearable Options for In-Clinic and In-Home Use

  • Released GlobalCardio 12 FLEX (“GC12 FLEX“), a complete remote 12- lead ECG acquisition and reading solution.
  • GC12 FLEX has been developed for use by clinics and telemedicine groups that operate from multiple locations and that require rapid and centralized ECG reading services through the use of automated algorithms or human ECG review.

Toronto, Ontario–(March 14, 2019) – CardioComm Solutions, Inc. (TSXV: EKG) (“CardioComm” or the “Company“), a provider of consumer heart monitoring and electrocardiogram (“ECG“) acquisition and management software solutions, has released GlobalCardio 12 FLEX (“GC12 FLEX“), a complete remote 12- lead ECG acquisition and reading solution. GC12 FLEX has been developed for use by clinics and telemedicine groups that operate from multiple locations and that require rapid and centralized ECG reading services through the use of automated algorithms or human ECG review.

The GC12 FLEX leverages two of the Company’s US Food and Drug Administration (“FDA“) and Health Canada Class II medical device approvals for the sale of a cloud-based ECG management software solution and an ECG viewing technology with automated ECG analysis and interpretation capabilities. ECGs can be captured using a standard one to 12-lead device, a 12-lead ECG belt or any CardioComm-qualified ECG monitoring device. Data can be uploaded to a centralized data store within the GC12 Flex Cloud solution via computer or through a smartphone using the GEMS™ Mobile app. ECG files may then be reviewed using an interpretive algorithm which will provide results in near real time. As soon as an ECG has been uploaded and reviewed, an email notification will go out to any healthcare professional associated with the monitored person and allow them to log in, review, over read and/or retrieve the ECG record.

The first installation of the newly-released GC12 FLEX solution is currently being implemented within a clinical research organization which will use the solution with CardioComm’s SMART Monitoring ECG reading service. The Company confirms it has strong market interest form customers, such as research organizations looking for a remote monitoring 12-lead ECG management solution that can include the provisioning of ECG triaging services. CardioComm’s ECG service can return a result within 30 minutes, 24 hours a day, 7 days a week or 365 days a year.

To learn more about CardioComm’s products and for further updates regarding HeartCheck™ ECG device integrations, please see 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 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.

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Posted in CardioComm Solutions | Comments Off on CardioComm Solutions $EKG.ca Releases Remote 12-lead ECG Telemed Solution with Arrythmia Detection and ECG Reading Services $ATE.ca $TLT.ca $OGI.ca $ACST.ca $IPA.ca

INTERVIEW: CardioComm Solutions $EKG.ca Continues Initiatives to Connect Your Heart To The Cloud $ATE.ca $TLT.ca $OGI.ca $ACST.ca $IPA.ca

Posted by AGORACOM-JC at 8:26 AM on Thursday, March 14th, 2019

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Posted in AGORACOM Via Satellite, CardioComm Solutions, Featured | Comments Off on INTERVIEW: CardioComm Solutions $EKG.ca Continues Initiatives to Connect Your Heart To The Cloud $ATE.ca $TLT.ca $OGI.ca $ACST.ca $IPA.ca

CLIENT FEATURE: CardioComm Solutions $EKG.ca – Connecting Your Heart To The Cloud $ATE.ca $TLT.ca $OGI.ca $ACST.ca $IPA.ca

Posted by AGORACOM-JC at 3:00 PM on Tuesday, March 12th, 2019

Global Leaders in Mobile  ECG Connectivity

  • 20 years of medical credibility licensing technologies to hospitals, physicians, remote patient monitoring  platforms, research groups and commercial call centers
  • Sold into > 20 countries, with the largest customer base located in the US
  • Class II medical device clearances and device agnostic for collecting, viewing, recording, analyzing and  storing of ECGs for management of patient and consumer health
  • ECG solutions for both consumer (OTC) and medical (Rx) markets
  • Owns all IP and source code
  • Market expert contributor for reports in m‐health, mobile cardiac monitoring and new advances in  consumer health and wellness monitoring

Recent Highlights

Innovation Continues as the FDA Clears CardioComm Solutions’ Novel ECG Smartphone App and Heartcheck(TM) Device for Direct to Consumer Sales Read More

  • Received approval from the US Food and Drug Administration for the over-the-counter sales and marketing of their device agnostic GEMS™ Mobile smartphone app and their newest handheld, heart rhythm monitor, the HeartCheckTM CardiBeat
  • Both have been cleared as a Class II medical device and are available for sale direct to consumers.

CardioComm Solutions’ HeartCheck(TM) Device Enters Final FDA Review Phase Read More

  • 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.
  • Company had submitted a letter of revocation of their supplementary information submission on December 26, 2018 in compliance with the FDA’s directive

CardioComm Solutions’ HeartCheck(TM) CardiBeat and Smart Phone App Enter Final Stage of FDA 510(k) Review Read More

  • Market Release of HeartCheck(TM) CardiBeat and GEMS(TM) Mobile Application Set For Early 2019
  • Completed its response to the USA Food and Drug Administration for additional information 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
  • HeartCheck™ CardiBeat is the second of several planned Bluetooth-enabled ECG recording devices to be marketed by the Company

An Innovator in the Mobile ECG Industry

Company Accolades

 FULL DISCLOSURE: CardioComm Solutions Inc. is an advertising client of AGORA Internet Relations Corp.

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Posted in AGORACOM Client Feature, All Recent Posts, CardioComm Solutions | Comments Off on CLIENT FEATURE: CardioComm Solutions $EKG.ca – Connecting Your Heart To The Cloud $ATE.ca $TLT.ca $OGI.ca $ACST.ca $IPA.ca

CardioComm Solutions $EKG.ca Prepares New FDA Applications for Direct-to-Consumer and Physician Use Cardiac Arrhythmia Algorhythms $ATE.ca $TLT.ca $OGI.ca $ACST.ca $IPA.ca

Posted by AGORACOM-JC at 8:43 AM on Tuesday, March 5th, 2019

Apps for Automated Atrial Fibrillation and Prolonged QT Interval Detection will be Included in the Scope of Detection Options

  • Preparing US Food and Drug Administration (“FDA“) 510(k) Class II medical device clearance applications for new arrhythmia detection algorithms.
  • Main application will be for GEMS™ Rhythm, a full suite of arrhythmia detection tools designed for use with GEMS™ WIN, which is licensed to hospitals, clinics and commercial ECG scanning services

Toronto, Ontario – (March 5, 2019) – CardioComm Solutions, Inc. (TSXV: EKG) (“CardioComm” or the “Company“), a global provider of consumer heart monitoring and electrocardiogram (“ECG“) acquisition and management software solutions, is preparing US Food and Drug Administration (“FDA“) 510(k) Class II medical device clearance applications for new arrhythmia detection algorithms.

The main application will be for GEMS™ Rhythm, a full suite of arrhythmia detection tools designed for use with GEMS™ WIN, which is licensed to hospitals, clinics and commercial ECG scanning services. GEMS™ Rhythm will support long-term, continuous recordings of ECGs that are associated with new and higher paying reimbursement codes in Canada and the US. GEMS™ Rhythm will also be capable of running on smartphones, removing the dependence on access to cloud-based systems for the collection and interpretation of ECG data.

The Company will also seek approvals for GEMS™ Rhythm AF and GEMS™ Rhythm QT for consumer and prescription use. These auto-detection algorithms will be available as add-on features to the recently FDA- cleared GEMS™ Mobile app, the only iOS and Android smartphone ECG app that can connect to different manufacturers’ ECG monitoring devices. GEMSTM Mobile with Rhythm AF will compete against solutions from AliveCor, Apple and others.

GEMS™ Rhythm QT would be the first QT interval prolongation screening solution released for smartphone use. QT interval abnormalities have been associated with sudden cardiac death sometimes seen in athletes and in patients prescribed certain medications. These abnormalities are better detected by devices like CardioComm’s HeartCheck™ ECG PEN and HeartCheck™ CardiBeat, both of which allow a lead II ECG trace to be recorded.

The ability for GEMS™ Mobile to link consumer use of ECG devices to hospitals where GEMS™ WIN is licensed extends the patient monitoring experience beyond the fixed and short-term use of traditional, large and expensive ECG monitoring devices. This should lead to better patient care outcomes and open additional billing code revenue-generating opportunities for health care organizations.

To learn more about CardioComm’s products and for further updates regarding HeartCheck™ ECG device integrations please see 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 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.

Tags: , , , ,
Posted in All Recent Posts, CardioComm Solutions | Comments Off on CardioComm Solutions $EKG.ca Prepares New FDA Applications for Direct-to-Consumer and Physician Use Cardiac Arrhythmia Algorhythms $ATE.ca $TLT.ca $OGI.ca $ACST.ca $IPA.ca

Innovation Continues as the FDA Clears CardioComm Solutions’ $EKG.ca Novel ECG Smartphone App and Heartcheck(TM) Device for Direct to Consumer Sales

Posted by AGORACOM-JC at 9:30 AM on Monday, February 25th, 2019

The HeartCheck(TM) CardiBeat and GEMS(TM) Mobile App Supports Both iOS and Android Smartphones for use in Consumer, Clinical Research and Telemedicine Cardiac Monitoring Solutions

  • Received approval from the US Food and Drug Administration (“FDA“) for the over-the-counter sales and marketing of their device agnostic GEMS™ Mobile smartphone app and their newest handheld, heart rhythm monitor, the HeartCheckTM CardiBeat
  • Both have been cleared as a Class II medical device and are available for sale direct to consumers.

Toronto, Ontario–(February 25, 2019) – 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 from the US Food and Drug Administration (“FDA“) for the over-the-counter (“OTC”) sales and marketing of their device agnostic GEMS™ Mobile smartphone app and their newest handheld, heart rhythm monitor, the HeartCheckTM CardiBeat. Both have been cleared as a Class II medical device and are available for sale direct to consumers.

Of significance is the GEMSTM Mobile smartphone app, a slimmed down version of the Company’s hospital-based software named Global ECG Management System (GEMSTM). In addition to supporting CardioComm’s own CardiBeat device, GEMSTM Mobile is the only ECG management iOS and Android smartphone app that has the ability to connect to several different manufacturers’ ECG monitoring devices. The first release of GEMSTM Mobile will give people the choice to work with up to two other handheld ECG monitors, both of which are already cleared for sale by the FDA in the US.

CardioComm was the first company to bring an ECG device and software to market for direct to consumer sales in North America and to enable anyone to see their ECG without a physician prescription. Software is the keystone element for such innovations and CardioComm expects to leverage the GEMS™ Mobile app in bringing new and additional advancements to personalized health and remote patient monitoring solutions.

The Bluetooth enabled and rechargeable CardiBeat allows a medical grade ECG recording to be taken by holding the device in both hands or by holding the device in the right hand and against the left side of the chest. This second option is more accurate for diagnosing arrhythmias such as atrial fibrillation and atrial flutter. This represents a significant diagnostic advantage over other devices currently on the market.

GEMS™ Mobile allows Smartphones and tablets to receive ECGs from HeartCheck™ devices for post-event or real-time/continuous cardiac monitoring. Feedback through the app is near-real-time and allows the user to view and generate a report of their own ECG which may be automatically shared with one’s physician. For those who want their ECGs reviewed, GEMS™ Mobile provides access to CardioComm’s SMART Monitoring ECG reading service for a professional review of the ECG for the presence of a number of potential arrhythmias.

GEMS™ Mobile is expected to be available on Apple’s App Store and on Google Play in March and will be free with the purchase of a HeartCheckTM ECG device. Pricing of the HeartCheckTM CardiBeat will be announced shortly.

To learn more about CardioComm’s products and for further updates regarding HeartCheck™ ECG device integrations please see the Company’s websites at www.theheartcheck.com and www.cardiocommsolutions.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 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.

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CLIENT FEATURE: CardioComm Solutions $EKG.ca – The heartbeat of Cardiovascular Medicine and Telemedicine

Posted by AGORACOM-JC at 3:54 PM on Wednesday, February 6th, 2019
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The heartbeat of cardiovascular medicine and telemedicine

  • Specializing in the software engineering of computer based electrocardiogram (heart monitoring) management and reporting software
  • Software permits physician interpretations of ECGs and supports private and public payer fee-for-service billings
  • ECGs are electrical recordings of the heart and performing an ECG is one of the most common diagnostic tests performed
  • Successfully launched technologies that enable the use of new medical devices and communication portals utilizing internet and cellular based technologies for the recording, transmission and viewing of ECGs

Recent Highlights

CardioComm Solutions’ HeartCheck(TM) Device Enters Final FDA Review Phase Read More

  • 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.
  • Company had submitted a letter of revocation of their supplementary information submission on December 26, 2018 in compliance with the FDA’s directive

CardioComm Solutions’ HeartCheck(TM) CardiBeat and Smart Phone App Enter Final Stage of FDA 510(k) Review Read More

  • Market Release of HeartCheck(TM) CardiBeat and GEMS(TM) Mobile Application Set For Early 2019
  • Completed its response to the USA Food and Drug Administration for additional information 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
  • HeartCheck™ CardiBeat is the second of several planned Bluetooth-enabled ECG recording devices to be marketed by the Company

Launched 12-Lead ECG Smart Wearable Garment Monitoring Solution Read More

  • Announced joint partnership sales plans for the commercial launch of its newest software release designed to support an innovative and easy to use wireless, 12 lead ECG, vital signs, arrhythmia and ischemia monitoring wearable smart garment manufactured by Israel-based HealthWatch Technologies Ltd.

Company to Receive Royalty Payments from Biotricity Read More

  • Confirmed progress on a royalty licencing agreement with Biotricty Inc.
  • Royalty payment phase became active following confirmation that all necessary clearance and software development pre-conditions have been achieved
  • Royalty fees are due from the use of the ECG software Cardiocomm developed, or any derivative products, on a per patient monitored basis

First Company to Receive Approval for ECG Product Sales Direct to Consumers Read More

  • CardioComm was the first company to be approved to sell an ECG product directly to consumers in North America as evidenced by OTC Class II medical device clearances by both the United States Food and Drug Adminstration and Health Canada in 2012
  • HeartCheck ECG PEN is currently available for OTC sales on the shelves of Canadian pharmacy chain Shoppers Drug Mart.

Completed HeartCheck(TM) Clinical Validation for Long-Term, Self-Managed, Remote Monitoring of Atrial Fibrillation Patients Post-Ablation Read More

  • Moved into routine clinical use following completion of a long-term, remote arrhythmia monitoring pilot in high risk patients.
  • PACE cardiologists have been prescribing use of the HeartCheck™ ECG PEN and ECG Handheld Monitor to their patients to provide up to one year of enhanced remote patient monitoring for arrhythmias in addition to use of conventional but term-limited Holter and event monitoring.

Products

HeartCheck™ Pen

The HeartCheck™ PEN handheld ECG device is the only device of its kind cleared by the FDA for consumer use.


✓ Monitor For Arrhythmias Anywhere
✓ Web Access to a Qualified Physician
✓ No Prescription Required

 
The pocket-sized PEN allows you to take heart readings from anywhere, the moment symptoms appear.

The HeartCheck™ ECG Device

The FDA-cleared HeartCheck™ ECG device is portable, easy to use and can store up to 200 thirty second ECG readings.

Whether at home, the gym or at the office, the HeartCheck™ ECG Device with SMART Monitoring can help detect and monitor arrhythmias from wherever you are.  

  Features & Benefits
✓ SMART Monitoring ECG Interpretations
✓ Cleared by the Food and Drug Administration (FDA)
✓ Easy to use
✓ Accurate heart readings in only 30 seconds
✓ Store up to 200 ECGs

Company Accolades


FULL DISCLOSURE: CardioComm Solutions Inc. is an advertising client of AGORA Internet Relations Corp.

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