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GUILFORD, Conn. - Hyperfine, Inc. (NASDAQ:HYPR), a $78.62 million market cap medical device company whose stock has surged 26.25% in the past week, has begun rolling out its Optive AI™ software to existing Swoop® system customers across U.S. hospitals and neurology offices, the company announced Wednesday. According to InvestingPro analysis, the company appears fairly valued at current levels.
The software, which received FDA clearance in late May 2025, enhances portable MRI brain imaging by improving noise cancellation, image acquisition, reconstruction, and post-processing. The upgrade provides greater clarity, uniformity, and sharper anatomical detail in brain scans.
Initial clinical users have reported significant improvements. Dr. Jennifer Villa Frabizzio, Chief of Neuroradiology at Jefferson Abington Hospital, noted that FLAIR images show "markedly improved resolution and are 40 seconds faster" compared to previous versions.
The software update is compatible with first-generation Swoop® systems without requiring hardware modifications. It is currently available in the U.S., Canada, Australia, and New Zealand, with additional international approvals expected later this year.
Hyperfine’s Swoop® system is an FDA-cleared portable, ultra-low-field magnetic resonance imaging device designed for brain imaging in various clinical settings where traditional MRI may not be practical.
"This is more than a software update—it’s a milestone that reflects our commitment to sustained innovation, improved clinical performance, and driving the adoption of portable brain MRI across multiple sites of care," said Maria Sainz, President and CEO of Hyperfine, in the press release.
The company plans to extend the software to all current customers in the coming weeks, enabling portable MRI technology to be used beyond intensive care units to emergency rooms and outpatient settings.
In other recent news, Hyperfine, Inc. reported its Q1 2025 earnings, revealing a shortfall in both earnings per share (EPS) and revenue compared to forecasts. The company experienced a net loss of $9.4 million, or $0.12 per share, which was slightly below the anticipated EPS of -$0.1167. Revenue was reported at $2.1 million, missing the projected $2.89 million. Additionally, Hyperfine announced the first commercial sales of its next-generation Swoop portable MRI system to two hospitals in the northeastern United States. This comes shortly after the system received FDA clearance, marking a significant milestone for the company. The Swoop system, enhanced by the proprietary Optive AI software, promises improved image quality and faster acquisition times. The FDA clearance of this portable MRI scanner is expected to broaden its clinical applications. Hyperfine’s advancements in AI software have also been highlighted, with Optive AI reportedly enhancing image clarity and nearing the quality of traditional MRI scanners.
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