London-based medtech startup Acurable is expanding to the US following regulatory clearance for its sleep-tracking device.
Acurable is based on more than 10 years of research conducted by Professor Esther Rodriguez-Villegas at Imperial College London’s Wearable Technologies Lab.
The AcuPebble can now diagnose obstructive sleep apnoea by monitoring respiratory biomarkers. Acurable said it will launch the device in the US this summer after receiving approval from the Food and Drug Administration – a key milestone for medtech companies breaking into the American market.
“We have already had a lot of interest from US clinicians, who believe it can be transformational for the millions of Americans who have undiagnosed sleep apnoea, putting them at risk of other serious health conditions,” said Rodriguez-Villegas, who is the company’s co-founder and co-CEO.
Traditionally diagnosis of obstructive sleep apnoea requires patients to be first trained on the equipment. This approach is open to retests because sensors can become disconnected or placed in the wrong position. It also requires a sleep specialist to analyse the data collected.
However, with the AcuPebble, patients wear the device on the front of their neck and data is transmitted to the app.
The sleep device is already used by the NHS along with a University of California San Francisco sleep apnoea clinical trial, according to the medtech.
“The AcuPebble has been game-changing for our patients, as it is a much simpler and comfortable experience,” said Dr Michael Harrison, founder of Magnap, a US company developing surgical treatments for obstructive sleep apnoea.
“It enables clinicians to conduct multiple night studies at a time, improving patient outcomes by giving them a much speedier diagnosis.”
Kibo Ventures led a €11m Series A into the company in October.
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