CardioComm Solutions Inc. recently announced that it has signed an agreement for integrating the new Aera CT MCT monitor from TZM into its GEMS software. The new GEMS MCT solution will be marketed and distributed under the name of GEMS Aera CT.

In a release, John Lubisich, TZM president, said that, “GEMS Aera CT will provide an efficient and cost-effective alternative for real-time, continuously-attended ambulatory cardiac monitoring for cardiac patients by combining the internet, the Aera CT's wireless (cellular) communication, leading-edge heart monitoring technology and CardioComm Solution's GEMS based software. In doing so, it will provide constant detection, recording, transmission and analysis of cardiac rhythm dysfunctions while the patient is fully mobile.”

Under the terms of the deal, CardioComm Solutions will be a global distributor for the Aera CT device and will be the exclusive distributor of the system in Canada. TZM will become a distributor for the GEMS Area CT software when it is combined with sales for its Aera CT device.

Etienne Grima, CEO of CardioComm Solutions, said that, “Few companies have been able to address the need for a more beneficial mobile arrhythmia monitoring tool. The majority are large IDTFs that produce their own proprietary MCT device which was restricted for use within their own customer base. TZM has engineered the first FDA cleared OEM MCT device which, with our GEMS software, will enable small and large IDTF and medical call centers to now enter the MCT market, a market which represents a significant revenue generating opportunity. The MCT market is USA specific where CMS approved reimbursement for this diagnostic test is particularly favorable at $754.”

GEMS Aera CT will see an initial deployment with IDTF and healthcare facilities which include medical clinics and hospitals which are currently using the GEMS software solution from CardioComm Solutions. Further deployments will be carried out at facilities which cannot provide MCT services as they don't have commercially available MCT solution that is based on a dependable and advanced software back end.

Bob Doerr, project manager for TZM said that, “There are more than 4 million people in the U.S. alone receiving care for recurring arrhythmias. Between 2000 and 2030, the number of people over the age of 65 will double, meaning there will be a sharp rise in the need for remediation of cardiovascular disease and associated heart ailments. The need for MCT monitoring will increase substantially, and we feel TZM is positioned well to contribute to meeting those demands. Furthermore, together with the HeartCheck devices, this development extends our prescription line of products and will add to our credibility in both disease management and consumer markets.”

In other news, CardioComm Solutions, Inc. recently received confirmation from the Canadian Medical Devices Conformity Assessment System (CMDCAS) that it had cleared an ISO audit performed by DQS Medizinprodukte GmbH. CardioComm Solutions is registered under Health Canada's Therapeutic Products Programme (TPP) according to ISO 13485:2003 and CMDCAS as well as MDD regulations, for the “Manufacturing and Distribution of Health Management Software Systems and Distribution of Health Monitoring Devices.”

The mission of the TPP, and the purpose of the audit, is to ensure that drugs, medical devices, and other therapeutic products available in Canada are safe, effective and of high quality.