Medical device company Creo Medical Group plc (AIM: CREO) announced on Wednesday that it has received clearance from the U.S. Food and Drug Administration for its SpydrBlade Flex device, a multi-modal endoscopic tool designed for precision and versatility in minimally invasive therapeutic endoscopy.

SpydrBlade Flex, already launched in Europe on 20 March 2025, combines laparoscopic cut-and-seal capability within a flexible endoscopic format. Clinical applications already include Z-POEMs, pedunculated polyps, fibrotic cases and general dissections, underlining its broad utility and ease of adoption.

FDA approval enables immediate commercial rollout in the US, supported by Creo's direct sales team and established clinician network. Existing reimbursement codes and the American Medical Association's 28 May 2025 decision to approve codes for endoscopic submucosal dissection provide a favourable reimbursement landscape, accelerating uptake.

SpydrBlade Flex expands Creo's advanced energy gastrointestinal product range, which includes Speedboat UltraSlim, Speedboat Notch and MicroBlate Fine. All devices are powered by CROMA, Creo's electrosurgical platform featuring adaptive Kamaptive technology for precise and controlled surgical outcomes.

Creo Medical is focused on transforming surgical and endoscopic procedures through safer, less invasive and more cost-effective solutions enabled by its proprietary energy platform and device suite.