FDA Clears trophon3: Over 40% Faster Cycle Time and Major US Market Launch

FDA Clearance Opens US Market for trophon3

Nanosonics Limited, a leader in infection prevention technology, has received US Food and Drug Administration (FDA) clearance for its latest innovation, the trophon3 device, along with a software upgrade package called trophon2 Plus. This regulatory milestone enables the company to launch these products commercially in the United States, a critical market for medical device adoption.

Faster, Smarter Disinfection Technology

The trophon3 device boasts a cycle time more than 40% faster than its predecessors, addressing a key operational bottleneck in ultrasound probe disinfection. Beyond speed, it integrates seamlessly with digital hospital systems, including compatibility with DICOM; the international standard for medical imaging data. This enhanced traceability ensures hospitals and clinics can monitor disinfection processes with unprecedented precision, improving patient safety and regulatory compliance.

Significant Market and Upgrade Opportunities

Nanosonics is targeting approximately 30,000 new device opportunities across US hospitals and private physician practices. Additionally, the launch unlocks a substantial upgrade market, around 10,000 first-generation trophon EPR devices worldwide could be replaced with trophon3, while 20,000 existing trophon2 devices are eligible for the trophon2 Plus software upgrade. This dual approach of new sales and upgrades positions Nanosonics to expand its installed base and deepen customer relationships.

Strategic Implications and Future Growth

CEO Michael Kavanagh highlighted that these innovations set a new benchmark in automated high-level disinfection, combining efficiency, safety, and environmental responsibility. The FDA clearance not only validates the technology but also signals Nanosonics’ commitment to advancing infection prevention standards globally. As healthcare providers increasingly prioritize patient safety and operational efficiency, trophon3’s enhanced features could accelerate adoption and market penetration.

While the announcement stops short of providing explicit financial forecasts, the scale of the upgrade and new device opportunities suggests meaningful revenue growth potential. Investors will be watching closely how quickly Nanosonics can convert these opportunities into sales and how competitors respond to this technological leap.