Recently, the U.S. Food and Drug Administration (FDA) approved a system for cleaning flexible endoscopes' complex internal channels for the first time. These channels are a stubborn source of hospital-acquired infections. This breakthrough was achieved by Nanosonics' automated CORIS device.

According to reports, Nanosonics' CORIS device is specifically designed to address stubborn biofilms formed in the narrowest areas of endoscopes. These areas cannot be reached by manual scrubbing during conventional reprocessing. Residual material composed of patient cells may gradually develop resistance to high-level disinfectants over multiple cleaning cycles.

An Australian company pointed out that studies on gastroscopes and colonoscopes found biofilm residues present in the fine channels of all devices, and some hospital-acquired infection outbreak events could be traced back to specific antibiotic-resistant strains carried within these reusable instruments.

Previously, the FDA has urged medical technology developers and healthcare institutions to switch to using disposable components (such as endoscope tip covers) or fully disposable endoscope systems, and has been tracking instrument contamination and serious postoperative infection cases for many years.

It is worth mentioning that Nanosonics' CORIS disinfection system has received de novo clearance from the U.S. FDA for medical devices, initially approving its use in conjunction with the Olympus Evis Exera III system, specifically designed for colonoscopy. At the same time, the company stated that it plans to gradually cover all major categories of flexible endoscopes.

Michael Kavanagh, President and CEO of Nanosonics, stated in a statement: "The company is continuously advancing its commercialization preparations, including obtaining the necessary approvals in the UK, Europe, and Australia. These approvals are expected to be completed in the first quarter of the 2026 fiscal year." At that time, the company will initiate the first phase of its commercialization process, focusing on targeted hospital pilot programs.

"At the same time, we are preparing to submit our first 510(k) application for expanded indications to the FDA," Kavanagh added.

It is estimated that 60 million endoscopic procedures are performed worldwide each year, with each operation relying on manual brushing and rinsing of the internal equipment, and more than half of these cases occur in the United States. In addition to CORIS, Nanosonics is also positioning itself in the ultrasound probe reprocessing equipment market through its Trophon series of products.

The CORIS system can be installed above the sink and automatically injects patented formula friction cleaners into the endoscope channels, followed by air flushing to remove internal residues. According to the manufacturer's instructions, the outer surface of the endoscope still needs to be cleaned separately according to standard procedures.