Fortive’s Advanced Sterilization Products (ASP) unit has secured CE mark approval for its ULTRA GI™ Cycle, a hydrogen‑peroxide gas‑plasma sterilization system designed for duodenoscopes. The approval allows the cycle to be sold and used throughout the European Union, addressing a long‑standing infection‑control challenge associated with these complex endoscopic devices.
The CE mark also gives existing customers of the STERRAD 100NX system with ALLClear™ Technology a straightforward upgrade path, while new customers can adopt the technology immediately. ASP’s partnership with FUJIFILM Healthcare Europe extends the cycle’s compatibility to the company’s ED‑840T and ED‑840XT duodenoscope models, broadening the potential market for the ULTRA GI™ Cycle across Europe.
Fortive’s recent financial performance underscores the strategic importance of this regulatory milestone. In the third quarter of 2025, the company reported earnings per share of $0.68, beating consensus estimates of $0.58, and revenue of $1.03 billion, up from $0.99 billion in the same period a year earlier. The earnings beat was driven by disciplined cost management and a favorable product mix, while revenue growth reflected strong demand in core segments. Management has cautioned that the fourth‑quarter 2025 guidance—projected EPS of $0.82 versus $1.17 a year earlier—will be lower, citing macro‑economic headwinds and a shift in customer spending patterns.
Chad Rohrer, President of ASP, said the CE mark “is a meaningful step forward in our mission to make duodenoscope reprocessing safer across Europe.” Pierre Emeric, Vice President of R&D, added that adding the new FUJIFILM duodenoscope models “further expands the breakthrough technology platform and demonstrates ASP’s commitment to innovation.” Ivan Salgo, MD and VP & Chief Medical Officer, highlighted that the partnership “has resulted in a sterilization approach that exceeds current industry benchmarks.”
The approval strengthens Fortive’s infection‑prevention portfolio and positions ASP as a leader in duodenoscope sterilization. It also supports the company’s broader strategy of delivering high‑margin, recurring‑revenue solutions—an approach that has been a focus since Fortive acquired ASP from Johnson & Johnson in 2019 for approximately $2.7 billion. With more than 20,000 STERRAD 100NX systems installed worldwide, the new CE‑marked cycle is expected to drive additional sales and reinforce ASP’s maintenance and service contracts, contributing to Fortive’s long‑term growth trajectory.
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