Liverpool-based medtech firm Enteral Access Technologies (EAT) has been awarded the CE Mark for its patient safety device DoubleCHEK. The award means that the company, which has already signed a deal with distributor Medicina, can now market the product for sale across the EU.

The device is an enteral feeding system designed to assist medical professionals in safely and quickly placing naso/oro gastric tubes for patients who cannot be fed orally. The device, which is designed to be used in any environment, utilises CO2 and pH indicators alongside a proprietary valving system.

The device is intended to reduce instances of potentially fatal tube misplacement. Estimates suggest that between 3-5 per cent of naso/oro gastric tubes are misplaced in the patient’s airway. Of these errors, around 33 per cent are thought to result in serious illness or even death.

Commenting on the award of the CE Mark, EAT’s founder and CEO George Gallagher said: “We are pleased to now be able to affix the CE Mark to our DoubleCHEK device. The team has worked hard to achieve this milestone, which gives our shareholders confidence that their belief in DoubleCHEK was well placed.”

“This achievement, together with our UKCA Mark and application to US FDA for the 510(k), means the regulatory outlook for DoubleCHEK is excellent. The market opportunity for our product is now far greater and we are excited to now be able to take this patient safety technology to clinicians throughout Europe.”

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