Creo Medical obtains FDA clearance for Speedboat RS2 and CROMA
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.
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.
"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.”
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.