“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 U.S. Food and Drug Administration (FDA) as well,” said Geoffrey Gill, president of Shimmer Americas, and co-founder of the Open Wearables Initiative (OWEAR).
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.
It takes only five minutes for a CRO to set up a new participant on the Verisense platform. The system provides status alerts to let them know if a sensor is being worn incorrectly, a base station is unplugged, or a sensor’s power is running low. Plus, the sensor has up to 44 days of memory on board, allaying any concerns about lost data.
Clinical trial participants can put on their Verisense IMU and forget about it. The device can be worn in the shower, its battery lasts for up to six months, and all the data it collects is uploaded daily to a secure cloud-based server, and encrypted, without any action required on their part.
The global consumer wearables market has grown dramatically during the past decade, reaching more than $10 billion in annual revenue by some estimates. But the COVID-19 crisis has significantly increased interest in, and adoption of, medical wearables.
“We believe that the medical wearables market will ultimately dwarf the consumer market, but it will be composed of many specific niches,” said Martina Donohue, marketing manager at Shimmer Sensing. “Medical products, such as the Verisense IMU, require a much higher level of specificity and accuracy than their consumer counterparts and a management system tailored to the specific use case. As a result, there will not be a one-size-fits-all medical mass market solution and the price points will be much higher.”