In an agency first, the FDA has cleared a system designed to clean out the complex inner channels of flexible endoscopes—a notorious source of hospital-acquired infections.
Nanosonics’ automated CORIS device targets the tough biofilm that can build up within the narrowest spaces of the endoscope, which can’t be reached by manual brushing during standard reprocessing. These residues, made up of patient cells, can also develop resistance to high-level disinfection over the course of multiple cleaning cycles.
According to the Australia-based company, studies of gastroscopes and colonoscopes have found biofilm residues within all of the hardware’s minute channels, and outbreaks have been traced back to single strains of antibiotic-resistant bacteria found within the reusable devices.
The FDA has previously urged medtech developers and healthcare providers to transition to endoscopes with disposable pieces, such as end caps, or single-use systems altogether. The agency has also worked for years to track cases of device contamination and serious post-procedure infections.
The de novo clearance for Nanosonics’ approach initially greenlights CORIS’ use with an Olympus video endoscope designed for colonoscopy, the Evis Exera III. The company said it plans to cover all major categories of flexible endoscopes in time.
“The company continues its preparations for commercial launch including obtaining the necessary approvals in the U.K., Europe and Australia. These approvals are expected to be in place during Q1 of FY26,” Nanosonics President and CEO Michael Kavanagh said in a statement. At that time, the company plans to begin its first phase of commercialization with a targeted hospital rollout.
“In parallel, the first 510(k) submission for expanded scope indications is being prepared for FDA submission,” Kavanagh said.
The company estimates 60 million endoscopy procedures are performed annually—relying on manual brushing and flushing of the hardware each time—with more than half conducted in the U.S. Nanosonics also markets ultrasound probe reprocessing equipment with its Trophon line.
Mounted over a sink, the CORIS system delivers a proprietary, friction-based cleaning agent to the endoscope channels through an automated cycle that then rinses and purges the internal passages with air. The endoscope’s external surfaces still need to be cleaned and reprocessed, according to the manufacturer’s instructions.