European market opens up for MedTech firm after receiving CE mark
Liverpool-based Enteral Access Technologies (EAT), a medical device company, has received the CE Mark for its DoubleCHEK device, a crucial regulatory requirement which enables the company to market its innovative patient safety product in all EU countries.
The CE milestone comes after the company recently obtained a UKCA mark and signed an agreement with Medicina, a large healthcare distributor.
It marks another achievement for the firm after securing funding in December, as many medical device companies stall or fail before securing a CE mark. The certification opens up a market worth $1.3bn by 2027.
Despite many complications for companies trying to export to Europe since Brexit, the EAT team anticipate the high impact nature of the device, together with distribution agreements, will help them overcome trade barriers and see increased trade in a sector where the UK has a competitive advantage.
DoubleCHEK is an enteral feeding device that uses CO2 and pH indicators, coupled with a proprietary valving system, to help clinicians place naso/oro gastric tubes safely and quickly in any environment. Enteral feeding is used when patient cannot receive their nutrition orally.
Misplacement of feeding tubes can result in serious patient harm, and often happens because clinicians make decisions on placement with limited information. It is estimated that three, to five per cent of all NG tubes inserted are misplaced into the airway, and 33% of those misplacements result in serious morbidity, such as pneumonia or pneumothorax, or even death.
DoubleCHEK provides clinicians with critical information to avoid NG tube misplacement.
George Gallagher, founder and CEO of EAT, 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.”
