16th June 2020

CE Marking For Five New Creo Devices

Creo Medical Group has secured CE marking of five new devices.

The listed medical device company, which is focused on the emerging field of surgical endoscopy, said the devices form the Creo GI (gastro-intestinal) suite of advanced energy devices across four technology platforms. The CE marking of the full range of products provides EU and UK clearance ahead of their commercial launch.

Creo expects to introduce the devices into clinical practice and prepare for commercialisation in the second half of the year.

The range is designed to be used with the CROMA Advanced Energy Platform (CROMA).

The individual device technology platforms each have multiple potential market applications, Creo said, including open surgical applications, several laparoscopic surgical and ablation markets as well as the core focus, initially, in the therapeutic flexible endoscopy markets.

Creo’s first product, Speedboat Inject is already CE marked, FDA cleared, and is being used by clinicians in the UK, EU, US, Africa and APAC. SlypSeal Flex – previously referred to as HS1 – received US FDA 510k clearance in March 2020.