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.
Predictmedix AI launches mobile diabetes screening platform in India
Navamedic's medical device OraFID approved as primary package for a pharmaceutical product
Speranza Therapeutics partners with Sunshine Labs for harm reduction solutions
Immuno Cure and PharmaJet collaborate for novel HIV therapeutic DNA vaccine advancement
GRAIL reports positive results from Galleri multi-cancer early detection test registrational study
InspireMD secures CE Mark approval for CGuard Prime EPS under European MDR
Crossject advances paediatric development of ZEPIZURE Junior for epilepsy crisis management
Creo Medical secures FDA clearance for SpydrBlade Flex in US market
Tissue Regenix secures CE and UKCA certifications for OrthoPure XT
Terumo Corporation expands stroke portfolio in EMEA with SOFIA Flow 88 catheter launch
Crossject advances ZENEO manufacturing with scalable aseptic filling module ahead of product rollout
ZYLOX Unicorn Vascular Closure Device approved in Indonesia
Mindray unveils BeneVision V Series at Euroanaesthesia 2025, advancing precision monitoring
Unicon Pharma and VRR Life Sciences partner support digital transformation in life sciences