Hyperfine unveils FDA-cleared next-gen portable MRI

GUILFORD, Conn. - Hyperfine, Inc. (NASDAQ:HYPR), a pioneering health technology firm with a strong balance sheet holding more cash than debt, announced the FDA clearance of its latest innovation, a new portable MRI scanner enhanced by its proprietary Optive AI™ software. This advancement is set to improve the portable MRI experience for clinicians and patients, offering high-quality brain imaging across various care settings. According to InvestingPro data, the company maintains a healthy current ratio of 6.07, indicating robust short-term financial stability.

The redesigned Swoop® system, informed by five years of global usage, promises superior image quality, functionality, and user experience. With a focus on a high signal-to-noise ratio, the system, alongside Optive AI™ software, delivers improved resolution, uniformity, and faster image acquisition. These improvements are anticipated to broaden the system’s clinical applications and adoption in diverse healthcare environments. While the company’s revenue grew by 34% in the last twelve months, InvestingPro analysis indicates the company is currently undervalued, suggesting potential upside for investors looking to capitalize on the healthcare technology sector.

The system’s patient-centric design aims to make MRI scans more accessible, particularly benefiting pediatric, elderly, or anxious patients. Its usability enhancements are expected to streamline the scanning process for healthcare providers.

Maria Sainz, President and CEO of Hyperfine, expressed confidence in the new Swoop® system’s potential to expedite adoption and enhance patient and provider satisfaction. The company plans to roll out the system in hospital and office settings across the United States.

Clinical partnerships, such as with Jefferson Abington, have been instrumental in refining the new system. Dr. Jennifer Villa Frabizzio, a neuroradiologist at the Radiology Group of Abington, highlighted the system’s ability to improve patient comfort and operational efficiency, noting the synergy between hardware and software as key to bringing portable MRI into mainstream clinical practice.

The Swoop® system is currently being evaluated in the NEURO PMR study, with participating sites reporting positive feedback. Dr. Laszlo Mechtler, Medical Director of Dent Neurologic Institute and principal investigator of the study, praised the system’s image quality and compact, cost-effective design as advantageous for neurology practices seeking to offer on-site brain imaging.

Hyperfine’s launch marks a significant step towards its vision of transforming global MRI access. By integrating AI with a reimagined portable MRI platform, the company aims to redefine the delivery of brain imaging across various care settings, enhancing accessibility, efficiency, and impact.

The Swoop® Portable MR Imaging® (V2) System is FDA-cleared for brain imaging for all ages and represents a mobile, ultra-low-field MRI device for head imaging where full examination is not feasible.

This news is based on a press release statement from Hyperfine, Inc.

In other recent news, Hyperfine Inc. reported its Q1 2025 earnings, revealing a net loss of $9.4 million and revenue of $2.1 million, which fell short of the anticipated $2.89 million. This earnings miss highlights challenges in meeting market expectations, despite a slight improvement in the company’s gross margin to 41.3%. Hyperfine remains optimistic about its future, projecting full-year revenue growth of 10-20% over 2024, with significant growth expected in the latter half of 2025. The company plans to launch its next-generation software and expand into the emergency department MRI market. Additionally, Hyperfine received FDA clearance for its Optive AI™ software, which enhances the image quality of its portable MRI system, Swoop®. This development is expected to support the company’s growth strategy by expanding into new hospital care sites and entering the neurology office market. Hyperfine’s financial stability is reinforced by a cash runway extended to the end of 2026, supported by a recent $6 million financing.

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