The Movesense Medical ECG and movement sensor, developed by the Finnish medical device manufacturer Movesense, has been certified as a Class IIa medical device in conformity with the European Medical Device Regulation 2017/745 (MDR).
Movesense Medical (MD) is a wearable sensor intended for measuring single channel ECG, heart rate, heart rate variability and human motion. The company says it becomes the first MDR certified chest strap ECG and heart rate monitor and one of the first ECG devices overall that have completed the MDR certification.
Movesense MD is suitable for remote patient monitoring and other telehealth applications. The patient can operate the device independently, which reduces the workload of care personnel and enables monitoring when needed. In ECG monitoring, this can help detect arrhythmias that are often not found in 24h Holter measurements.
Movesense MD introduces a new price point for ECG devices that helps to expand care coverage and reach new patient groups. In addition to healthcare use, the device scales to clinical trials, population health programs, well-being, and sports. It is also the first MDR compliant heart rate monitor that provides continuous, ECG-based heart rate data for heart rate variability analysis.
Movesense CEO Jussi Kaasinen, said: “The MDR certification of the Movesense MD sensor is a major milestone for Movesense and our EU customers, as it enables large-scale clinical use of the device and allows ECG monitoring for larger patient groups and in new usage situations.”
