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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.

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 3:08 PM on Tuesday, March 19th, 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

Check Out Our Recent Interview

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

INTERVIEW: CardioComm Solutions $EKG.ca Is Connecting Your Heart To The Cloud

Posted by AGORACOM-JC at 12:09 PM on Thursday, February 21st, 2019

CardioComm is a leading global provider of consumer heart monitoring and ane electrocardiogram (aka “EKG”) solutions.  Their products are sold in over 20 countries and they’ve received numerous awards over the years.

So what does that mean?

If you’ve ever had to have your heart checked out, you know the experience involves going to a hospital / clinic and being hooked up to machines that make you look like you’re plugged into the matrix.  A technician takes a bunch of readings and a doctor tries to come up with a status of your heart’s condition.

PROBLEM 1:  It is a terribly outdated system.  You have to leave work.  The hospital / clinic has to buy & maintain a bunch of machines.  The process is very time consuming.  The entire problem also gets a lot worse if you don’t live near a major city with great hospitals, doctors and equipment.

PROBLEM 2: WORSE of all, if your heart is playing nice that day and isn’t showing signs of problems that have got your worried, you don’t get a proper diagnosis and / or you may have to come back again.

SOLUTION?  You guessed it >> CardioComm.  Thanks to the combination of your smartphone + an app and some tiny nodes to place on your chest, your heart can be monitored at length during normal activity to get you the best diagnosis possible.  The results are shot up to the cloud, where they are remotely analyzed by doctors / technicians that can then speak to you directly, or get you into a hospital ASAP.

This is the simplified version.  Now watch CEO Etienne Grima give you the deep dive in a way that will actually have you on the edge of your seat yearning for more.

If you love the transition of big existing things to digital, then you are going to love what CardioComm does.  Grab a cup of coffee and watch this.

CardioComm Solutions $EKG.ca Engages US Law Firm to Address Licensing and IP Opportunities

Posted by AGORACOM-JC at 10:16 AM on Thursday, February 21st, 2019


  • Move is Part of Growing Sales, Marketing and Strategic Partnership Activities in the United States
  • confirms it has retained Whiteford, Taylor & Preston L.L.P. to assist in software licensing and intellectual property business matters on a go forward basis.

Toronto, Ontario–(February 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 it has retained Whiteford, Taylor & Preston L.L.P. to assist in software licensing and intellectual property business matters on a go forward basis.

Whiteford, Taylor & Preston includes over 170 attorneys in sixteen offices located in Delaware, the District of Columbia, Kentucky, Maryland, Michigan, New York, Pennsylvania and Virginia, and is one of the mid-Atlantic’s leading law firms.

As new opportunities develop in the US, the Company will be well served with representation from a firm located in the United States with experience in identifying, protecting, expanding and leveraging the Company’s technologies and IP assets. Further, Whiteford, Taylor & Preston meets the Company’s need for guidance from a firm with expertise in working with a medical software company that does business in both hospital and large institutional environments, as well as the consumer health and wellness sectors.

To learn more about CardioComm’s products and for further updates regarding software releases and new 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 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.

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
Logo large

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.

CardioComm Solutions’ $EKG.ca HeartCheck(TM) Device Enters Final FDA Review Phase

Posted by AGORACOM-JC at 9:45 AM on Tuesday, January 29th, 2019

HeartCheck(TM) CardiBeat and GEMS(TM) Mobile review results expected in late February

  • Completed a request for additional information from the US Food and Drug Administration for the Company’s premarket notification 510(k), Class II medical device clearance application for the HeartCheck™ CardiBeat and GEMS™ Mobile Application.

Toronto, Ontario–(January 29, 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 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.

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 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.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/42519