Creo Medical Group's Speedboat RS2 device and Croma platform received FDA 510(k) clearance.
Here's what you should know:
1. Speedboat RS2 allows for the minimally invasive removal of bowel-based early stage cancerous and precancerous lesions.
2. The FDA cleared Creo Medical Group's devices in only 49 days, which the developer said was ahead of schedule.
3. Because of the accelerated approval, Creo is analyzing how it can accelerate its U.S. commercialization plans.
4. Speedboat RS2 is the company's first device to be used with Croma. The Croma platform enables both cutting and coagulation.
5. Creo CEO Craig Gulliford said in a release, "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 European Union, U.S. and globally."