Shimmer Research, a wearable technology specialist has received CE Certification for its ECGmd holter monitor electrocardiograph (ECG).
The device is now a CE certified, class IIa medical device under the Medical Device Directive (93/42/EEC).
Geoffrey Gill, president of Shimmer Americas commented: “We are delighted to report that we can now deliver robust ECG data wirelessly from a CE-certified wearable medical device.
“Shimmer has more than a decade of experience developing ECG sensors and it’s evident in this device. We developed a five-wire, four-lead ECG system to ensure that it would produce the very detailed, low noise signal required by healthcare professionals and medical researchers. Patients will also benefit from its lighter, low-profile form.”
The device weighs about 40% as much as an average holter monitor (39.32 grams versus 99 grams) and presents a slimmer format (measuring just 100 mm x 33 mm x 8 mm).
It was developed for Shimmer’s original equipment manufacturer (OEM) business as a small, high-quality ECG for system integrators to incorporate into their products. Therefore, the device is supplied in kit form with only the hardware and firmware included in order for clients to develop their own display software.
Additionally, Shimmer is prepared to submit a 510(k) application to the FDA for the ECGmd if needed by OEM customers.
Please note: Shimmer’s ECGmd is not intended for use as an unattended critical care monitor.