ECGmd is now recognized as a medical device in Europe, capable of providingmedical-grade ECG output from Shimmer’s wearable sensor
Shimmer Research, a global leader in wearable technology for research applications, today announced that ECGmd – its five-wire, four-lead holter monitor electrocardiograph (ECG) – is now a CE certified, Class IIa medical device under the Medical Device Directive (93/42/EEC).
“We are delighted to report that we can now deliver robust ECG data wirelessly from a CE-certified wearable medical device,” said Geoffrey Gill, president of Shimmer Americas.
“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,” Mr. Gill added.
Shimmer’s ECGmd weighs only about 40 percent as much as an average holter monitor (39.32 grams versus 99 grams) and it presents a slimmer format, measuring just 100 mm x 33 mm x 8 mm.
The ECGmd was developed for Shimmer’s original equipment manufacturer (OEM) business as a small, high-quality ECG for system integrators to incorporate into their products. As a result, it is supplied in kit form with only the hardware and firmware included so that clients can develop their own display software. Shimmer is also prepared to submit a 510(k) application to the FDA for the ECGmd if needed by OEM customers.
Shimmer’s ECGmd is not intended for use as an unattended critical care monitor.
About Shimmer Research
Founded based on Intel technology in 2006, Shimmer Research is a well-established wearable technologies services and sensor manufacturing company based in Dublin, Ireland. In addition to standard products, Shimmer provides customized sensor development services, volume manufacturing, and complete wearable sensor solutions of any complexity. Shimmer’s technology and services have been employed by thousands of researchers at more than 900 leading companies, universities, and research institutes in more than 75 countries. Shimmer’s technology is incorporated in the products and services of more than 20 original equipment manufacturers. Shimmer has an ISO 13485:2016 certified medical devices quality management system. For more information, visit www.shimmersensing.com, https://www.linkedin.com/company/shimmer/ or follow @ShimmerSensing.