Creo Medical (CREO) , a medical device company focused on minimally invasive surgical endoscopy, has received 510(k) clearance from the US Food & Drug Administration for its Speedboat UltraSlim device.
FDA clearance allows Creo to initiate the launch of UltraSlim in the US through its existing direct sales channels and supported by its network of key opinion leaders and clinicians.
This clearance follows recent guidance received from the company's notified body of an EU regulatory pathway, which has accelerated the European launch of the UltraSlim device by approximately 18 months.
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Another regulatory milestone achieved for Creo in quick succession, marking a significant leap forward for its medical device solutions. Speedboat UltraSlim removes bowel cancer lesions, preventing their malignant development. Bowel cancer is the fourth most common cancer in the UK, with almost 43,000 people diagnosed every year. Speedboat reduces the chances of recurrence of a lesion from 15% to 1% and potentially provides a cure for lesions containing early cancer without requiring surgery.
Approval of the Speedboat UltraSlim in the US reaffirms its status as one of the leading advanced endoscopy services, helping it to move closer to its goal of prevention, early detection, and treatment of bowel cancer.
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