Nanosonics, an Australian medical equipment manufacturer, has received De Novo clearance from the U.S. Food and Drug Administration (FDA) for its CORIS system, marking a significant advancement in endoscope reprocessing technology. The CORIS system is designed to automate and enhance the cleaning of internal channels in flexible endoscopes, addressing a critical infection control challenge in healthcare settings.
The FDA clearance specifically covers the use of CORIS for colonoscopes, with plans to expand the approval to all major categories of flexible endoscopes over time. This regulatory milestone represents the first automated cleaning system specifically designed for endoscope channels to receive FDA clearance.
Market Response and Commercialization Timeline
Following the announcement, Nanosonics shares climbed 12.8% to $4.93 (AEDT), building on impressive gains of more than 80% over the past 12 months. The company has confirmed that the first phase of CORIS commercialization remains on schedule for the first quarter of fiscal year 2026.
The initial rollout will involve a limited market introduction in select hospitals to gather real-world performance data. Pending successful results from this first phase, Nanosonics plans to begin broader market introduction in the second half of FY26.
Beyond the U.S. market, the company is actively pursuing regulatory approvals in the United Kingdom, Europe, and Australia, with expectations to secure these approvals during Q1 FY26.
Addressing a Critical Infection Control Challenge
Flexible endoscopes, particularly their internal channels, present significant challenges for thorough cleaning and disinfection. These narrow, complex channels can harbor biofilm and bacteria, potentially leading to cross-contamination between patients if not properly reprocessed.
Michael Kavanagh, CEO and President of Nanosonics, emphasized the system's innovative approach: "The CORIS system has been designed to automate and provide superior cleaning outcomes for the channels of all categories of flexible endoscopes."
The technology specifically targets the internal channels of endoscopes where traditional manual cleaning methods may be less effective and consistent. By automating this critical step in endoscope reprocessing, CORIS aims to enhance patient safety by reducing the risk of healthcare-associated infections.
Technical Innovation in Endoscope Reprocessing
The CORIS system represents a technological advancement in endoscope reprocessing workflows. Current guidelines for flexible endoscope reprocessing typically involve multiple steps, including pre-cleaning, manual cleaning of channels, high-level disinfection, and proper storage.
The manual cleaning step has been identified as particularly variable and dependent on technician technique. By automating this process, CORIS potentially offers more consistent and thorough cleaning of endoscope channels, addressing a recognized weak point in infection prevention protocols.
While the initial FDA clearance covers colonoscopes, which are among the most commonly used flexible endoscopes, Nanosonics has indicated plans to expand the approved applications to include gastroscopes, duodenoscopes, bronchoscopes, and other specialized endoscopes used across various medical specialties.
Healthcare facilities increasingly focus on improving endoscope reprocessing as regulatory scrutiny and awareness of infection risks have intensified. The CORIS system enters the market as healthcare systems seek more effective and efficient solutions to ensure the safety of endoscopic procedures, which are performed millions of times annually worldwide.
