Nanosonics (ASX:NAN) has reached an important regulatory milestone after the United States Food and Drug Administration granted 510(k) clearance that broadens the range of endoscopes compatible with the company’s CORIS system.
The decision marks the first expansion of the technology’s approved indications and represents another step in the company’s strategy to extend the system across a wider variety of endoscope types.
The clearance builds on the earlier De Novo authorisation that allowed CORIS to be used with its initial endoscope indication. With the first expansion now secured, Nanosonics is advancing its development roadmap and preparing a second 510(k) submission that will further extend the system’s endoscope coverage.
CORIS is part of Nanosonics’ broader focus on infection prevention technologies for healthcare environments. The expanded clearance immediately increases the number of endoscopes that can be processed using the system, helping hospitals and healthcare providers strengthen infection control practices while streamlining reprocessing workflows.
At the same time, the company has begun introducing the system through a controlled market release program in the United Kingdom. Additional sites are expected to be added in the United Kingdom and Ireland, with Australia set to follow soon. According to Nanosonics, the controlled release program is designed to gather operational insights and user experience before expanding availability further.
Michael Kavanagh, Chief Executive Officer and President of Nanosonics, said the regulatory milestone keeps the company aligned with its planned development timeline and provides momentum for upcoming commercial activities. He noted that the company intends to begin controlled market release sites in the United States after gaining early experience from the United Kingdom and Australian programs.
Looking ahead, Nanosonics expects to move toward a full commercial launch beginning in the 2027 financial year. The rollout is expected to occur region by region as each controlled market release program is completed and operational feedback is incorporated.