Shimmer Research, a company specializing in wearable devices for use in research applications, has announced its Verisense inertial measurement unit (IMU) sensor has been certified by the Conformitè Europëenne (CE) has a Class I medical device.
Geoffrey Gill, president of Shimmer Americas, told Outsourcing-Pharma, “Verisense’s certification as a medical device ensures that pharmaceutical companies, regulators, and others can rely on the quality and accuracy of the device.”
Now that the sensor has received approval in the EU, Gill told us, the company is in the process of applying for certification with the US Food and Drug Administration as well. He added that the Verisense unit is designed to meet the particular requirements of clinical trials and remote-monitoring application.
“It provides the continuous raw data needed to provide the ground truth for regulatory submissions and it collects data completely passively so that participants don’t need to do anything but wear it,” Gill explained. “It also has an advanced compliance monitoring system that can be configured to meet the widely varying needs of different trials.”
Gill added that the company designed the Verisense IMU and the wearables platform to be user-friendly, quick to set up and flexible.
“We designed Verisense with the needs of all the stakeholders in clinical trials – sponsors, clinical research organizations (CROs), clinical sites, and participants – in mind. Although there are certain common characteristics, such as the need for continuous raw data for sponsors and minimum burden for participants, different trials may have very different protocols and needs; we designed the system to be easy to adapt to those different needs,” Gill commented.
“The sensor operating parameters (such as sample rates) can be adjusted once for the entire trial. The compliance monitoring system can be easily configured using a single dashboard. This allows CROs and sponsors to meet the specific needs of their trials,” Gill added.
The system reportedly provides status alerts to let sites know if a sensor is being worn incorrectly, a base station is unplugged, or a sensor’s power is running low. Additionally, the sensor is designed to hold up to 44 days of memory on board, avoiding any concerns about lost data.
Gill reported Shimmer is working to expand the sensor capabilities to include optical heart rate, spO2, ECG, GSR, and other sensors. Additionally, the company is seeking to expand the number of form factors offered, with the first of the introductions expected to be made in early 2021.
Martina Donohue, marketing manager with Shimmer Sensing, said the company expects the medical wearables market will outpace the consumer market, and consist of a number of niches.
“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,” she said.