UK-based Creo Medical Group has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its Speedboat RS2 and CROMA platform.

Powered by the platform, Speedboat RS2 is designed to aid minimally invasive removal of early-stage cancerous and pre-cancerous lesions in the bowel using an endoscopic procedure.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Following the early receipt of FDA approval, the firm plans to implement the necessary plans for commercialisation of the surgical device in the US.

Creo Medical Group CEO Craig Gulliford said: "The FDA clearance of Speedboat RS2 and the CROMA system earlier than planned is a critical step in our commercialisation strategy.

“Speedboat is paving the way for our suite of GI devices, which we plan to commercialise in the EU, US, and globally.

"Speedboat is paving the way for our suite of GI devices."

"Over the coming weeks, we will be looking to bring forward the development of our US capabilities whilst continuing with the promising training programme under way in Europe.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Intended to minimise the risks associated with incisions that are required during a laparoscopic procedure, the device employs the cut and coagulation capability of CROMA to allow lesion removal.

Upon activation of microwave energy by the surgeon, Speedboat RS2 can coagulate bleeding vessels and can cut or resect when RF energy is activated.

This ability decreases the risk of tissue puncturing and provides a minimally invasive alternative with an improved safety profile to the surgeons.