Designed for public health research and clinical trials, the GENEActiv is a lightweight and waterproof raw data accelerometer.
The GENEActiv’s robust, neutral design can objectively monitor physical activity, sleep and everyday living behaviours reliably for up to one month without the need for charging.
Made in the UK to medical-grade standards, the GENEActiv is low burden for both patients and sites and can also produce environmental light and temperature measurements. The device can be worn by all age groups and can be fitted to various body locations including wrist, arm, back and leg.
Unfiltered Data Collection
The high resolution, unfiltered data adds great value to the data collection. It enables a reproduceable data set, as novel analysis techniques become available and in-depth machine learning techniques can be applied to investigate specific motions of behaviour (such as tremor or scratching) according to specific populations.
Investigating Novel Endpoints
Algorithms based on true raw data enable programmes to report digital clinical measures and investigate novel digital endpoints.
Utilising the raw data, we can develop algorithms to meet research objectives in generating precise insights from objective patient data outside of the clinic environment.
Features
Designed for 24-hour wear in both free-living and clinical studies
Can be worn continuously for up to 1 month without the need to charge
100% waterproof
Unfiltered raw data output includes acceleration in 3 axes
High resolution data capture between 10-100Hz
Records physical activity intensity and sleep/wake measurements
Open-source analytics and open SDKs available
Ambient light and temperature sensor
Neutral design to achieve maximum patient wear adherence
The GENEActiv is currently a Class I self-certified medical device under the MDD 93/42/EEC for CE Marking.
We are transitioning to the new Medical Device Regulation (EU) 2017/745 in 2023. Under the MDR the GENEActiv will become a Class IIa medical device.
FDA Compliance
The GENEActiv is currently FDA 510(k) exempt.
Products are made in the UK in cGMP accredited facilities, ISO 13485, ISO 9001.
Multiple Body Locations
The GENEActiv isn't just for measurement at the wrist and can be fitted to a number of other body locations including waist, arm, hip, ankle, chest, back and thigh.
Different Straps Available
Each GENEActiv device comes with a PU resin wrist strap as standard, however we have a variety of other straps available to suit all body shapes and ages from infants to elderly.
We also offer straps in different materials to accommodate for allergies and can provide coloured wrist straps for children.
What Else Do I Need?
When you buy a GENEActiv device, you will also need to purchase a USB cradle in order to charge, set-up the devices and download data once the collection period has ended.
Each charging cradle can hold up to 4 devices. Our team will be able to advise on how many cradles would be recommended for your study/number of devices.
Your devices will be supplied with black PU resin wrist straps as standard, however please contact us if you require different straps.
Our apps and software have been designed to enable healthcare professionals to configure devices and collect data remotely in the most efficient way possible. This gives complete control to the study to share data as required by the study protocol or project needs.
Activinsights’ commitment to open data formats and algorithms has provided a platform for hundreds of algorithm developers to create new techniques and measures from raw data to verify and validate new digital health measures.
Our friendly team have extensive experience in remote monitoring technology and can advise you on what products and services will best suit your project needs.
