
The £184 million tender, worth about $192 million U.S., will supply the NHS with HeartSense recorders across its primary and secondary care offices, as well as civil service departments, through its Integrated Care Boards.
The device carries a UKCA approval for Great Britain, and the company said it is working on obtaining a 510(k) clearance from the FDA.
Worn about the chest, the portable HeartSense is designed to fit men and women for home recording sessions as long as 12 hours at a time, and can be recharged with a wireless dock. It logs ECGs on-demand, with encrypted results that can be shared as a PDF with providers.
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The paired smartphone app also alerts the user on electrode placement, providing notifications if it needs adjustments.
“We did not have a UK ECG manufacturer and reporter until now,” Cambridge Heartwear founder Rameen Shakur said in a statement. “HeartSense is the world’s first medical-grade, AI-powered, multi-channel ECG wearable and demonstrates what can be achieved when clinicians, engineers and AI specialists work together.”
