Case Study

Awardwinning scanner secures FDA clearance

Date: October 6, 2018

VitalScan, a portable scanner that can help clinicians quickly rule out serious heart disease in patients, has been awarded medical device clearance from the Food and Drug Administration (FDA), opening up distribution in the USA.

The device, based on research by Professor Ben Varcoe of the University of Leeds, was supported by the IKC at proof of concept stage and is already CE marked. It uses the heart’s electromagnetic signals to carry out a rapid assessment of cardiac health, enabling healthy patients to be sent home without further costly tests or referrals.

Spin-out company Creavo Medical Technologies successfully raised £13.4m investment in 2017 to commercialise the device and make it ready for market. Creavo also won two Institute of Engineering and Technology awards – for best healthcare technology and best overall emerging technology design. A UK wide clinical trial of VitalScan is nearing end of recruitment. Creavo already has distribution agreements signed in several countries, with more in the pipeline and some distributors looking at running further trials.

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