FDAnews Device Daily Bulletin

Creo Gets FDA 510(k) Nod on Speedboat RS2 Device

Aug. 23, 2017

Creo Medical Group has secured FDA 510(k) clearance for its Speedboat RS2 device and CROMA platform.

The Speedboat RS2, which enables minimally invasive endoscopic removal of cancerous and precancerous lesions, was cleared ahead of schedule, according to the firm.

Creo CEO Craig Gulliford said the early approval gives the company confidence to move forward with the devices it has in development.

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