Creo Medical Group PLC (AIM:CREO) has received clearance from the US Food and Drug Administration (FDA) for its Speedboat UltraSlim device, paving the way for its launch in the United States.
The FDA 510(k) approval comes on the heels of recent EU regulatory guidance that has fast-tracked the new product's European launch by about 18 months.
Creo's UltraSlim model is a smaller version of Creo's existing Speedboat Inject, making it compatible with most endoscopes used in gastrointestinal procedures.
Targeting the treatment of gastrointestinal tract lesions and swallowing disorders, the device utilises advanced bi-polar radiofrequency and microwave energy for precise cutting and coagulation of tissue.
Regulator clearance significantly expands the range of clinicians and patients who can benefit from Creo's innovative technology.
"Our engineering team have overcome many challenges to scale the Speedboat technology down to the size of the UltraSlim, and, with the support of our regulatory team, we have been able to obtain FDA clearance with speed and efficiency," said chief executive Craig Gulliford.
"Together with the recent news of the accelerated regulatory pathway in the EU, we look forward to patients, clinicians and healthcare providers being able to benefit from the widespread commercialisation of Speedboat UltraSlim in both Europe and the US in 2024 and beyond."