Hyperfine has received clearance from the US Food and Drug Administration (FDA) for its Optive AI software, designed to enhance image quality for the Swoop Portable MR Imaging system.
According to the Nasdaq-listed health technology company, this development improves brain imaging by increasing clarity and anatomical detail. The software uses advanced artificial intelligence (AI) algorithms throughout the imaging process, from noise reduction to post-processing.
Hyperfine claimed that clinical sites testing the software have reported that its image quality is approaching that of traditional 1.5 tesla MRI scanners.
Hyperfine technology vice president Rafael O’Halloran said: “This software release marks the beginning of a transformative era for Hyperfine. The advanced AI algorithms integrated into our new software platform dramatically elevate image quality at ultra-low field strength, enabling more confident diagnoses at the point of care.
“We previewed Optive AI software at the recent American Society of Neuroradiology annual meeting and received outstanding feedback. It’s the strongest signal yet of where we’re headed—and how far AI-powered portable MRI imaging can go.”
The company plans to extend the rollout of the Optive AI software in Q3 2025. The Swoop system, already FDA cleared for patients of all ages, offers portable, ultra-low-field magnetic resonance images, suitable for situations where full diagnostic imaging is not feasible.
The system is CE marked in the European Union (EU) and UKCA marked in the UK and is available in select international markets.
Hyperfine chief operating officer Tom Teisseyre said: “Optive AI software is our tenth software release since initial FDA clearance and marks a critical inflection point in the evolution of Swoop system technology—the first of two major technology milestones we have been looking forward to this year.
“The significant image quality enhancements enabled by Optive AI software will serve as a catalyst for our 2025 growth strategy, supporting expansion into new hospital sites of care and our entry into the neurology office market.”
Earlier this month, Hyperfine reported its financial results for the first quarter of 2025, which show revenue at $2.1m, a decrease from $3.3m in the same period of 2024.
Six commercial Swoop systems were sold in this reported quarter. The net loss decreased slightly to $9.4m from $9.8m year-over-year, equating to $0.12 per share compared to $0.14 per share previously.
Hyperfine expects revenue for the first half of 2025 to be between $5m and $6m, with an anticipated annual growth rate of 10% to 20% over 2024.
