• Somfit®D (single-use) FDA-cleared, immediately doubling addressable U.S. market
• Expands access to estimated US$240M annual U.S. Home Sleep Testing market
• Complements reusable Somfit®, creating EEG-based platform for both single-use and multi-night reusable markets

Compumedics Limited (ASX: CMP) announced that the U.S. Food & Drug Administration (FDA) has granted 510(k) clearance for the Somfit®D device (K252383), authorising its sale in the United States. Somfit®D is a single-use Home Sleep Testing device engineered for national scale, addressing the U.S. market's demand for single-use solutions that reduce infection risk, shorten turnaround times, and enable high-throughput testing. In combination with the reusable Somfit®, Compumedics now delivers the only EEG-based platform that spans both single-use and reusable markets, offering true sleep architecture where competitors rely on indirect measures. The U.S. Home Sleep Testing market is worth up to US$240M annually, representing approximately 4 million studies each year, with growth estimated at up to 25 percent per annum. With Somfit®D now FDA-cleared, Compumedics will immediately commence commercialisation, leveraging a dedicated U.S. salesforce, established relationships with Independent Diagnostic Testing Facilities (IDTFs) and sleep centres, and a proven recurring revenue engine spanning SaaS subscriptions, consumables, and device sales.

Compumedics reaffirms FY26 guidance of at least A$70M revenues and A$9M EBITDA.

The FDA clearance of Somfit®D is a transformational milestone for Compumedics, positioning the company to capture meaningful share of the U.S. sleep diagnostics market worth up to US$240M annually and to accelerate its recurring revenue growth for years to come.