Vantaa, Finland — The Movesense Medical ECG and movement sensor, developed by the Finnish medical device manufacturer Movesense Ltd, 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 lightweight wearable sensor intended for measuring single channel ECG, heart rate, heart rate variability and human motion. It now 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.
An affordable ECG solution to reduce the workload of care personnel
Thanks to its unobtrusive wear and simple use, Movesense MD is especially 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 helps catch 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.
— 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, says Movesense CEO Jussi Kaasinen.
With its wireless Bluetooth communications, open APIs, and full access to raw data, Movesense MD is easily integrated into existing health applications. Its current use cases relate to cardiology, orthopedics, neurology, and more. The device software can be tailored to specific needs.
Movesense supports customers developing new solutions with Movesense Medical in their local conformity assessment process, such as the FDA in the US, by providing the sensor-related documentation required for the medical approval of the new system.
The MDR certified Movesense MD is available for immediate orders.
Movesense Ltd is a privately owned Finnish pioneer of wearable technology with an ISO 13485 certified medical device quality system. The company’s scalable, Finland-based manufacturing can supply programmable wireless ECG and movement sensors in any quantity from single units to commercial mass volumes.
Movesense website: www.movesense.com
Scientific publications: www.movesense.com/publications/
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