Hyperfine has received CE marking and UK Conformity Assessment approval for its next-generation Swoop portable MRI system and latest Optive AI software, enabling commercialisation across Europe and the UK. The approvals mark a key milestone in the company's international growth strategy. The next-generation Swoop system, FDA-cleared in Q2 2025, delivers improved image quality and workflow for brain imaging. The updated Optive AI software includes multi-direction diffusion-weighted imaging capabilities, enhancing stroke detection similar to high-field MRI scanners. The technology is currently distributed across over a dozen European countries through Hyperfine's network. The company plans to begin commercialisation of the new system and software in Europe and the UK in early Q3 2026, ahead of internal expectations.

Hyperfine Inc reported record fourth-quarter revenue of $5.3 million, up 128% year-over-year, driven by strong performance of its next-generation Swoop scanner. The medical imaging company sold 16 units in Q4, compared to nine units in the prior-year period. Gross margin expanded to 50.9%, up 1,530 basis points from Q4 2024, whilst net loss narrowed to $5.9 million from $10.4 million. Full-year 2025 revenue reached $13.6 million, up 5% from 2024. The company received FDA clearance for updated Optive AI software and gained approval for its first-generation Swoop system in India. Hyperfine reduced cash burn by 30% year-over-year to $5.7 million. For 2026, the company projects revenue of $20 million to $22 million, representing 55% growth at the midpoint, with gross margins of 50% to 55%.