Therapy Areas: Devices
Creo Medical receives US FDA clearance for Speedboat UltraSlim endoscopy device
1 November 2023 -

Medical device company Creo Medical Group plc (AIM: CREO) announced on Wednesday that it has received 510(k) clearance from the US Food & Drug Administration (FDA) for its Speedboat UltraSlim device.

This clearance enables the company to launch UltraSlim in the USA and follows an accelerated European launch based on recent EU regulatory guidance.

UltraSlim, the second brand in Creo's Speedboat family, offers reduced size and compatibility with most GI endoscopic procedures, expanding the reach of Creo's technology. The device targets therapeutic treatment of Gastrointestinal tract lesions and swallowing disorders, powered by Creo's CROMA advanced energy platform.

Creo Medical specialises in minimally invasive electrosurgical devices for endoscopy. Focused on improving patient outcomes, Creo develops advanced energy solutions, including the CROMA powered by Kamaptive technology, providing clinicians with flexible, precise, and controlled surgical solutions. The company aims to impact the surgical and endoscopy landscape by offering safer, less-invasive and cost-efficient options for procedures.