The heartbeat of cardiovascular medicine and telemedicine
Patented systems enable medical professionals, patients, and other healthcare professionals, clinics, hospitals and call centres to access and manage patient information in a secure and reliable environment
CardioComm Solutions, Inc. Profile
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
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.
CardioComm Solutions Releases Remote 12-lead ECG Telemed Solution with Arrythmia Detection and ECG Reading Services Read More
- Released GlobalCardio 12 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.
CardioComm Solutions Prepares New FDA Applications for Direct-to-Consumer and Physician Use Cardiac Arrhythmia Algorhythms Read More
- Preparing US Food and Drug Administration 510(k) Class II medical device clearance applications for new arrhythmia detection algorithm
- 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.
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 Now Offers a Smartphone Connected FDA Cleared 12 Lead ECG Belt Under a New Co-Marketing Agreement Read More
- 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 12 FLEX remote ECG patient management platform and its hospital-based GEMS™ WIN software.
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.
An Innovator in the Mobile ECG Industry
Last changed at 21-Mar-2019 11:50AM by AGORACOM