According to the press release, the Speedboat RS2 device and the associated CROMA energy platform received premarket clearance through the 510(k) process by demonstrating that the device is substantially equivalent to an existing legally marketed device. According to Creo, the FDA clearance was received earlier than expected. Expected to take roughly six months, the 510(k) process was completed just 49 days after submission.
The Speedboat RS2 device for endoscopic submucosal dissection is said to be the first of several devices planned for use with Creo’s CROMA radiofrequency and microwave generator. According to the announcement, the Speedboat RS2 is intended for removal of early stage cancerous and pre-cancerous lesions, and combines bipolar radiofrequency cutting and microwave coagulation for precise dissection and controlled hemostasis. The combined functionality is said to reduce the risk of puncturing tissue and enhances the safety profile of endoscopic lesion removal. According to Creo’s CEO Craig Gulliford,
Over the coming weeks, we will be looking to bring forward the development of our US capabilities whilst continuing with the promising training programme underway in Europe.