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.
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.
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).
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: EKG, electrocardiogram, mhealth, stocks, tsx 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
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).
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: EKG, stocks, tsx, tsx-v Posted in All Recent Posts, CardioComm Solutions | Comments Off on 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 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.
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.
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).
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.
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.
Products
The Project: Arrhythmia Screening and Medical Adherence
An Innovator in the Mobile ECG Industry
Company Accolades
FULL DISCLOSURE: CardioComm Solutions Inc. is an advertising client of AGORA Internet Relations Corp.
Posted by AGORACOM-JC
at 8:35 AM on Wednesday, February 13th, 2019
The Novel 12 Lead ECG Belt will be Marketed into the US Hospital and Telemed Markets
Entered into a device technology relationship for the co-marketing and US sales of a Smartphone connected 12 lead ECG wearable device
The announcement follows the successful integration and testing of the device with CardioComm’s GlobalCardio (“GC”) 12 FLEX remote ECG patient management platform and its hospital-based GEMS™ WIN software.
Toronto, Ontario–(February 13, 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 entered into a device technology relationship for the co-marketing and US sales of a Smartphone connected 12 lead ECG wearable device.
The announcement follows the successful integration and testing of the device with CardioComm’s GlobalCardio (“GC“)
12 FLEX remote ECG patient management platform and its hospital-based
GEMS™ WIN software. Joint sales efforts will be launched during the 2019
Healthcare Information and Management Systems Society (“HIMSS“)
Global Conference & Exhibition in Orlando this week. HIMSS is
expected to attract over 45,000 health information and technology
professionals, clinicians, executives and market suppliers from around
the world.
The device is a simple to use, 12 lead ECG belt that is placed around
the chest without the use of disposable supplies. The belt is intended
for in-home use under a physician’s prescription and can be placed
properly without the need for any medical training. Once the belt is in
place, ECGs are recorded and uploaded to a cloud service from where ECG
files are pulled into CardioComm’s software.
GC12 FLEX and GEMS™ WIN provide an FDA cleared, back-office solution
for centralized ECG data collection from remotely monitored patients.
Physicians and/or ECG reading services can access their data securely
for review and ECG reporting. GC12 FLEX also offers optional automated
ECG interpretation to ease the ECG review process. GC12 and GEMS WIN are
device agnostic solutions that offer healthcare professionals a
simplified, “one-software-for-all-ECG-devices” single platform solution.
CardioComm continues to seek out innovative hardware technologies
that will provide reliable ECG monitoring of people outside of a
hospital environments. The Company expects the 12 lead ECG belt will be
of interest to its current hospital and physician group customer base,
as well as to a growing number of remote and telemedicine patient
management providers that are looking for ways to add ECG monitoring to
their services. As part of the relationship the device manufacturer will
promote the use of the CardioComm software to its growing client list
looking to use 12 lead ECG monitoring within their operations.
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.
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).
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: ECG, tsx, tsx-v Posted in All Recent Posts, CardioComm Solutions, Featured | Comments Off on CardioComm $EKG.ca Solutions Now Offers a Smartphone Connected FDA Cleared 12 Lead ECG Belt Under a New Co-Marketing Agreement
Posted by AGORACOM-JC
at 3:54 PM on Wednesday, February 6th, 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) 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.
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).
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.
