Risk assessment wearable officially classed as medical device

A wearable solution which helps to identify certain health risks early on thereby enabling people to maintain their independence for longer, has been certified as an official medical device after conforming to EU standards. 

Developed by HAS Technology with support from Edinburgh Napier University and Scotland’s Digital Health and Care Institute (DHI), ARMED empowers users with access to data allowing for better self-management, whilst healthcare professionals can be quickly alerted to potential issues. 

Combining predictive analytics with wearable technology and health and social care data, ARMED can identify risks, such as a fall, by using this information to create a ‘risk profile’. As a certified medical device, in accordance with the Medical Device Directive (MDD), ARMED can now be used in clinical settings.

The ARMED clinical evaluation stated that a “proactive approach to falls is considered crucial” and “significant reductions in falls have been observed in trials when a risk of falling is identified, and the risk is managed.” It also highlighted that “evaluations to date have identified clinical trends in patient groups including dehydration, weight loss, restlessness nocturnally, muscle wasting and reduced grip strength,” all of which can be monitored by ARMED. 

Brian Brown, director of ARMED at HAS Technology, said: “We are delighted that ARMED has received certification as a medical device. Technology has a huge role to play moving forward and with so much evidence to support the benefits of early detection, this places ARMED in a much more credible position, especially within NHS spheres, to help make a real difference. 

“This process can usually take up to nine months but, with the herculean effort of my colleagues, we reduced that timescale by several months. I would like to take the time to thank them all for their hard work and dedication to getting this done.”

Dr Kes Khaliq, clinical director of DigiTEC Innovation, who supported the team through the process and signed off on the 52-page clinical evaluation report, added: “I am pleased to have helped support the ARMED team during this process, receiving this end result. ARMED has been shown to have a huge impact for users, identifying potential issues at an early stage - up to 32 days in advance - thereby looking after the patient and also relieving pressure on already strained services. It is great that its benefits have been officially recognised.”