Shimmer Research, a global leader in wearable technology for research applications, has announced that its Verisense Inertial Measurement Unit (IMU) sensor is now a CE certified, Class I medical device (#22286).
Shimmer Research receives CE certification for Verisense
Geoffrey Gill, President of Shimmer Americas, said: “Verisense IMU’s CE registration as a medical device validates Shimmer’s quality systems and its fitness for purpose for medical applications. We are delighted to have received this EU approval and are in the process of applying for registration with the US Food and Drug Administration (FDA) as well.”
The Verisense IMU plays a central role in Shimmer’s Verisense wearable sensing platform, which was developed from the ground up for use in clinical trials. Verisense addresses the needs of, and places minimum burden on, all clinical trial stakeholders – sponsors, clinical research organizations (CROs), site staff and participants.
For sponsors, Verisense captures continuous raw data for all the clinical trial metrics, ensuring that they have everything required for their regulatory submission package. It also delivers maximum data reliability and advanced trial management tools for easy use and increased data accessibility, transparency and security.
The global consumer wearables market has grown dramatically during the past decade, with the COVID-19 crisis significantly increasing interest in, and adoption of, medical wearables.
Marketing Manager Martina Donohue added: “We believe that the medical wearables market will ultimately dwarf the consumer market, but it will be composed of many specific niches. Medical products, such as the Verisense IMU, require a much higher level of specificity and accuracy … As a result, there will not be a one-size-fits-all medical mass market solution and the price points will be much higher.”
Donohue will discuss the evolution of the medical wearables market and associated technology at the IEEE First International Workshop on Wearable Sensors and Devices, Artificial Intelligence and Wearable Markets on 19 Nov.