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LONDON - Creo Medical (TASE:BLWV) Group plc (AIM:CREO) has received U.S. Food and Drug Administration clearance for its SpydrBlade Flex (NASDAQ:FLEX) device, the company announced in a press release statement.
The multi-modal endoscopic device is designed for precision in therapeutic endoscopy procedures and is the latest product in Creo’s Gastro-Intestinal suite to receive FDA clearance.
According to the company, SpydrBlade Flex delivers laparoscopic cut and seal functionality through an endoscopic device. The product was commercially launched in Europe on March 20, 2025, and has been used in various clinical applications including Z-POEMs, pedunculated polyps, general dissections and fibrotic cases.
The FDA clearance enables Creo to begin marketing SpydrBlade Flex in the U.S. through its existing direct sales force and established network of clinicians.
The company noted that many applications for SpydrBlade Flex fall under existing reimbursement codes, including those established by the American Medical Association on May 28, 2025, for endoscopic submucosal dissection.
Creo’s Chief Executive Officer Craig Gulliford called the clearance "an important commercial milestone" as the company has now received FDA clearance for its complete suite of advanced energy GI products for resection, dissection and ablation.
The SpydrBlade Flex joins Creo’s other GI products including Speedboat UltraSlim, Speedboat Notch and MicroBlate Fine.
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