SmartECG service will be a unique and revolutionary solution, an algorithm and service platform with which ECG data can be automatically analysed and interpreted.
SmartECG is the first and only automatic clinical decision support solution that will be compatible with 80 % of different ECG-monitoring devices and suitable for primary and secondary care professionals.
The validation process will begin in spring 2018 and we expect to finalize the CE marking process and to receive FDA clearance by 11/2018.
RemoteA has over 15 years of experience in running a Remote Diagnostic Service Platform, operated today in over 300 healthcare units in Finland, Sweden and United Kingdom. Over 70.000 ECG consultation reports has been delivered thus producing +1.5 million hours of cardiac data to develop the automatic analysis on. RemoteA has developed strong algorithm expertise on ECG data as welll as a wide network of cardiologists, tech and business experts.
RemoteA has delivered over 70.000 ECG consultation reports thus producing +1.5 million hours of cardiac data to develop the automatic analysis on. We have thus been able to create strong algorithm expertise on that ECG data.
Over the years we have worked with top cardiologists in developing our services, and continue to do so. The medically validated, highly secured telemedicine platform has been developed by our technical experts.
We are certified for ISO 13485 and we follow the European directive for medical devices (MDD) and the US FDA Quality System Regulations (QSR) in our quality processes and product development.
Additionally, we operate in conformance with the main MD industry standards (IEC 62304, IEC 60601-1, ISO 14971 and IEC 62366) as well as product specific standards (IEC 60601-2-47, ANSI/AAMI EC57). Our product portfolio includes several CE marked medical devices with both software and hardware products.
SmartECG service is co-funded by the Horizon 2020 programme that helps high-potential SMEs to develop groundbreaking ideas for products, services or processes ready to face global competition.