Agoracom Blog Home

Posts Tagged ‘EKG’

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

CardioComm Solutions $EKG.ca Completes Work on Arrhythmia Detection Algorithms with Artificial Intelligence-Based Learning

Posted by AGORACOM-JC at 9:11 AM on Thursday, January 10th, 2019


  • Collaboration with the University of Victoria opens the pathway to three FDA applications
  • Leading the way to a release of artificial intelligence enhancements to CardioComm’s Global ECG Management Solution and reporting software technologies

Toronto, Ontario–(January 10, 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 completion of a six month collaborative project with researchers at the University of Victoria, Canada, leading the way to a release of artificial intelligence (“AI“) enhancements to CardioComm’s Global ECG Management Solution (“GEMS™”) and reporting software technologies (“GEMSTM Rhythm“).

GEMS™ Rhythm will support the management of large‐scale, long-term ECG data recordings on computers and smartphones.

CardioComm provides innovative software solutions for information management systems in cardiovascular medicine, telemedicine and consumer markets supporting near real-time ECG transmitting devices for a range of ECG monitoring use cases including recording periods from a few seconds to up to 30 consecutive days. CardioComm’s software is device-agnostic providing a market advantage by allowing it to be plug and play with many different approved outpatient and over-the-counter (“OTC“) ECG recording devices. Not all such devices are capable of ECG arrhythmia classification and so the burden of analysis will reside server-side in the hands of ECG technicians and physicians or on Smart devices as point of care diagnostic tools. New generations of wearable and smaller devices with less firmware based processing capabilities are being developed that will place more ECG management responsibility software side.

GEMS™ Rhythm will provide fast and accurate review of very large ECG data pools and will address important challenges in the denoising and processing of ECG data where recording quality is not optimal or where ECGs are recorded from different devices with different sampling rates. While GEMS™ Rhythm classifies ECGs for the presence of clinically-relevant abnormalities, it will do so while using much less computational power, allowing it to be run much faster on weaker platforms such as embedded microcontrollers. GEMS™ Rhythm will also be capable of running on smartphones, removing the need for immediate access to cloud-based systems for the collection and interpretation of ECG data.

The work conducted with the University of Victoria was funded in part by the Government of Canada through an Engage Grant set up to facilitate university-industry partnerships. Under the terms of the grant, any intellectual property (“IP“) arising from the project belongs to CardioComm. The Company expects to use the IP in three separate FDA software-as-a-medical device applications. The first application will be for GEMS™ Rhythm itself, which will provide a full suite of arrhythmia detection tools designed to support hospital and ECG scanning service installations of GEMSTM. The second and third applications, named GEMS™ AF and GEMS™ QT, will both be marketed as smartphone applications used for AF detection and QT interval determination, respectively. QT interval abnormalities are seen simply as aberrantly shorter or longer parts of an ECG trace that is associated with sudden cardiac death. These interval abnormalities are sometimes seen in athletes and in patients prescribed certain medications.

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.

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

Posted by AGORACOM-JC at 10:01 AM on Monday, January 7th, 2019

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) 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

CardioComm Solutions’ $EKG.ca HeartCheck CardiBeat FDA 510(k) Review Extended

Posted by AGORACOM-JC at 6:52 PM on Monday, December 31st, 2018
  • FDA Removes Additional Clinical Testing Requirements for the HeartCheck CardiBeat
  • Reduced the scope of their request for additional information for the Company’s premarket notification 510(k), Class II medical device clearance application for the HeartCheck™ CardiBeat and GEMS™ Mobile Application.

Toronto, Ontario–(December 31, 2018) - 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 USA Food and Drug Administration (“FDA“) has reduced the scope of their request for additional information for the Company’s premarket notification 510(k), Class II medical device clearance application for the HeartCheck™ CardiBeat and GEMS™ Mobile Application. 

CardioComm submitted its most recent 510(k) application to the FDA for Class II Medial device clearance on the HeartCheck™ CardiBeat as previously reported. The Company was then requested by the FDA to provide additional data that included clinical evaluations to confirm the device’s ability to record ECGs equivalent to those using conventional ECG electrode patches and ECG cables. 

Subsequent to receiving the Company’s reply with additional data, the FDA provided guidance on two primary items. These were:

  1. the Company no longer was required to support the request for extensive ECG electrode testing data; and,
  2. additional data was requested related to Bluetooth wireless coexistence testing.

In compliance to the FDA’s directive, the Company has submitted a letter of revocation of their supplementary information submission which was accepted by the FDA on December 26, 2018. The Company will provide the FDA a restatement of their response for additional information to the FDA by January 23, 2019 without clinical ECG testing data and with the requested wireless coexistence data. The FDA will have 31 days to complete the 510(k) review following receipt of CardioComm’s restated submission.

The Company will provide updates on this and future 510(k) applications. 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.comand 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, Inc. $EKG.ca – The heartbeat of Cardiovascular Medicine and Telemedicine

Posted by AGORACOM-JC at 2:21 PM on Thursday, December 27th, 2018
EKG: TSX-V

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) 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

CardioComm Solutions $EKG.ca HeartCheck(TM) CardiBeat and Smart Phone App Enter Final Stage of FDA 510(k) Review

Posted by AGORACOM-JC at 9:26 AM on Friday, November 23rd, 2018

Logo large

  • 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

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 completed its response to the USA Food and Drug Administration (“FDA“) 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.

The 510(k) application started its 90 day Substantive Review by the FDA on June 8, 2018. The FDA requested additional information from the Company regarding the device July 27, 2018, which stops the clock on the Substantive Review time line. The countdown of the 90 days will restart upon the FDA accepting the Company’s response to the requested additional information.

The FDA’s request for additional information required external and independent third party testing for electromagnetic and electrostatic discharge compatibility. The FDA also requested data confirming the device’s ability to record ECGs of equivalent clinical quality, as compared to ECGs recorded using conventional ECG electrode patches and ECG cables. CardioComm was provided a maximum of 180 days to reply to the FDA examiner. While the Company intended to respond to the FDA within 90 days, the requested testing and documentation through third parties did not allow a response to the FDA to be completed within this time frame. All device tests have now been passed and results compiled for the reply to the FDA. The Substantive Review clock will restart once the FDA receives and accepts the Company’s reply. Based on the FDA’s published timelines, the Company projects a possible completion of the 510(k) application review by the end of December 2018. The Company notes that the FDA has the ability to request more time to complete their review at the FDA’s discretion.

The HeartCheck™ CardiBeat is the second of several planned Bluetooth-enabled ECG recording devices to be marketed by the Company. The first was the Bluetooth HeartCheck™ECG PEN. As indicated in the Company’s May 22, 2018 press release, the GEMS™ Mobile Smartphone app will have compatibility with a number of different wireless ECG recording devices, including wireless 12 lead devices which will have direct applicability to remote patient monitoring and telemedicine markets.

The Company will provide updates on this and future 510(k) applications. 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. Refer to the Company’s May 22, 2018 press release for further information respecting the initial FDA filing.

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.