Agoracom Blog

CLIENT FEATURE: CardioComm Solutions $ – Connecting Your Heart To The Cloud $ $ $ $ $

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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