The latest software, the eighth generation of Swoop® system software, has obtained CE and UKCA approval

Hyperfine, Inc. the groundbreaking medical device company that has redefined brain imaging with the world’s first FDA-cleared portable magnetic resonance brain imaging system—the Swoop® system— announced the launch of the AI-powered eighth generation of Swoop® system software. The software’s diffusion-weighted imaging (DWI) AI denoising feature received U.S. Food and Drug Administration (FDA) clearance in October 2023, and it has been rolled out at select sites over the past several weeks through a limited market release. The latest software improves Swoop® system image quality and introduces valuable ease-of-use features, including a real-time aid for more precise patient loading and positioning and a streamlined image upload process.

With CE and UKCA certifications for this latest software, Hyperfine, Inc. is well positioned for future international expansion, bringing the Swoop® system to a broader global market.

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“Our latest AI-powered software, the eighth generation of our proprietary software platform, embodies our commitment to supporting clinicians in critical decision-making,” remarked Tom Teisseyre PhD, Chief Operating Officer of Hyperfine, Inc. “Our focus on image quality with this latest software has been on the DWI sequence, which is key in stroke imaging. Since its first FDA clearance in 2020, we’ve been dedicated to continually enhancing image quality and workflow efficiencies to define best-in-class, user-centric, ultra-low field MR brain imaging.”

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Over 50 exams were performed in hospitals taking part in the limited market release phase, and users commented favorably on DWI image quality. Participating sites confirmed that the new streamlined upload feature materially shortened upload completion times, and the fast-positioning check was a time-saving aid and helped improve image acquisition.

“The software update on the Swoop® system has been most beneficial to our workflow. We are now able to view each series as it is being performed and can communicate with the technologist whether additional series are needed. Additionally, we can communicate with clinicians any critical findings in real-time without having to wait for the whole study to be completed,” says Jennifer Villa Frabizzio MD, neuroradiologist, Radiology Group of Abington.

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Hyperfine, Inc. will roll out software updates for the Swoop® system to users in the coming weeks.

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Latest Swoop software improves image quality for DWI imaging of the brain

Hyperfine, the groundbreaking medical device company that created the Swoop system, the world’s first FDA-cleared portable magnetic resonance imaging (MRI) device for imaging of the brain, announced the U.S. Food and Drug Administration (FDA) 510(k) clearance and launch of the company’s upgraded AI-powered software.

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The most recently cleared Swoop software improves the image quality of the diffusion-weighting imaging (DWI) sequence with increases in its signal-to-noise ratio. An additional update in this software release increases the Swoop Portable MR Imaging System field of view by 10% for T1, T2, and FLAIR sequences to match the previously improved DWI sequence’s 20cm field of view. Field of view size is important for visualizing pathology deep in the brain.

“The latest Swoop software improves image quality with notable improvement in the appearance of the DWI images. The improved image quality more clearly displays underlying brain structure, further accentuating diffusion positivity and potentially increasing confidence in image interpretation and clinical decision-making,” said Edmond Knopp, M.D., senior medical director of Hyperfine, Inc.

“Our team continues to make rapid and significant software advancements for our first-in-class ultra-low-field Swoop Portable MR Imaging System to deliver diagnostic-quality brain images that enable timely clinical decision-making at the point of care,” said Maria Sainz, president and CEO of Hyperfine, Inc. “We are committed to continuous improvement to optimize the clinical utility of the Swoop system while driving commercial adoption across leading institutions globally. We have released two new sequences (T1 Standard and Fast T2) in the last twelve months, improved DWI sequence image quality twice, and expanded the system’s field for view.”

Hyperfine, Inc. first received initial FDA clearance for the Swoop Portable MR Imaging System in 2020 and has received two additional FDA clearances for hardware improvements and seven clearances for upgraded software, including BrainInsight software—with five of these clearances received in 2022. Hyperfine, Inc. maintains a total installed base* of 100 Swoop systems globally, and twenty peer-reviewed clinical publications have included Swoop system data.

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“We’re investing heavily in software development, AI, and image quality and are committed to expanding the toolbox available to our users,” said Tom Teisseyre, chief product officer of Hyperfine, Inc. “These initiatives are core to our transformative approach to MR imaging, making it a reality for a growing number of patients in the fast-evolving diversity of sites of care.”

As of Hyperfine, Inc.’s third-quarter 2022 earnings report on November 10, 2022. The Swoop system total installed base consists of commercial system installations (which make up total revenue), grant fulfillment installations, and research unit installations. The Swoop system total installed base (or total installed units) is the number of Swoop^® devices deployed to hospitals, other healthcare providers, and research institutions. We view the total installed base as a key metric of the growth of our business and is measured from period over period.

Hyperfine, is the groundbreaking medical technology company that created the Swoop system, the world’s first FDA-cleared portable magnetic resonance imaging (MRI) system capable of providing neuroimaging at the point of care. The Swoop system received initial U.S. Food and Drug Administration (FDA) clearance in 2020 as a bedside magnetic resonance imaging device for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The Swoop^® system has been approved for brain imaging in several countries, including Canada and Australia, has UKCA certification in the United Kingdom, and is also available in New Zealand and Pakistan.

The mission of Hyperfine, Inc. is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging, and data solutions. Founded by Dr. Jonathan Rothberg in a technology-based incubator called 4Catalyzer, Hyperfine, Inc. scientists, engineers, and physicists developed the Swoop^® system out of a passion for redefining brain imaging methodology and how clinicians can apply accessible diagnostic imaging to patient care. Traditionally, access to costly, stationary, conventional MRI technology can be inconvenient or not available when needed most. With the portable, ultra-low-field Swoop^® system, Hyperfine, Inc. is redefining the neuroimaging workflow by bringing brain imaging to the patient’s bedside.

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Viz.ai, the leading AI-powered disease detection and intelligent care coordination platform, announced it is partnering with Hyperfine, Inc., creator of the first FDA-cleared point-of-care magnetic resonance imaging (MRI) device, Swoop. Together, they will bring MRI to the patient’s bedside and deliver valuable insights to the clinician’s fingertips for timely decision making.

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“With this partnership, we will be able to combine Viz’s intelligent care coordination platform and leading image viewer with the Hyperfine Swoop Portable MR Imaging System.”

The mission of Viz.ai is to fundamentally improve how healthcare is delivered in the world through intelligent software that promises to reduce time to treatment, improve access to care, and increase the speed of medical innovation. Viz.ai’s flagship product, Viz LVO, leverages advanced deep learning to communicate time-sensitive information about stroke patients straight to a specialist who can intervene and treat. In stroke, speed matters, as delays in care can lead to severe morbidity and mortality.

Swoop, the world’s first MR imaging system capable of providing neuroimaging at the point of care, expands patient access to MRI by bringing imaging to the bedside. The Swoop system allows physicians to make quick and informed clinical decisions for patients, eliminating hours of wait and transport time and reducing the potential for adverse events associated with transporting critically ill patients.

This partnership and subsequent implementation in neuro ICUs provide the potential to further decrease the time from admission to treatment by expediting clinician access to MRI imaging and increasing access to time-critical diagnostics in the acute and post-acute care phase.

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“The partnership between Hyperfine and Viz.ai will help us integrate two breakthrough technologies that already enable us to better assess patients in a time-critical fashion and make timely decisions that will ultimately save more lives and improve outcomes,” said Shahid M. Nimjee, MD, PhD, Associate Professor of Neurosurgery, Surgical Director of the Comprehensive Stroke Center, The Ohio State University Medical Center. “By combining these two proven technologies, we hope to further expedite care, when every second matters and transportation presents additional risk.”

“Partnering with Hyperfine to enhance the clinical workflow and expedite the clinical team’s access to imaging has the potential to result in better patient outcomes where time is critical in the ER and ICU,” said Jayme Strauss, chief clinical officer at Viz.ai. “With this partnership, we will be able to combine Viz’s intelligent care coordination platform and leading image viewer with the Hyperfine Swoop Portable MR Imaging System™.”

“This new partnership between Viz.ai and Hyperfine has the potential to enable healthcare providers to reduce neuroimaging wait times, streamline their clinical workflow coordination, and improve patient care from door to discharge,” says Scott Huennekens, executive chairperson of the board of Hyperfine.

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Hyperfine, Inc., creator of the Swoop Portable MR Imaging System, the world’s first US FDA-cleared portable magnetic resonance imaging (MRI) device, announced that it has completed registration and notification of the device in Australia and New Zealand. With this activity, the Swoop system is now available for purchase in Australia and New Zealand and includes the US FDA-cleared advanced reconstruction software using deep learning. Multiple pilot research units have been ordered across key Australian cities bolstering Hyperfine’s entry into these two markets and laying the foundation for commercial efforts.

Hyperfine is pleased to announce the appointment of Quantum HealthCare as the company’s distributor for Australia and New Zealand. Now part of Paragon Care Limited, Quantum is a leading independent high-end medical equipment distributor across Asia Pacific. Quantum specializes in state-of-the-art medical imaging and patient treatment equipment distribution and services for leading global suppliers. Quantum HealthCare General Manager Tiffany Chiew said, “Quantum is very excited to be distributing Hyperfine’s mobile MRI technology in Australia and New Zealand. Together with the news of our recent merger with Paragon Care, we are optimistic about the acceptance and growth of Hyperfine’s innovative technology in the region.”

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“Australia and New Zealand have a population of 31 million people spread across a vast geographic area. Providing relevant and critical MR imaging services to people of these two countries is further challenged by the historical all-in-costs of conventional MRI systems. Swoop runs on regular wall power and is simple to use. The portable Hyperfine Swoop MRI system requires no special room build-outs and is available at the patient’s bedside, enabling new care scenarios. We have been excited to learn of the early success of Alfred Health and are excited about other upcoming sites deploying Swoop,” said Dave Scott, president and chief executive officer of Hyperfine.

The Hyperfine Swoop system has been in use for research purposes at Alfred Health in Melbourne since mid-late 2021. “In the largest ICU in the southern hemisphere, point-of-care MR imaging has impacted the diagnosis and evaluation of intensive care patients in Melbourne. Reducing the staff and time needed in transporting very ill patients to the medical imaging department improves outcomes for patients. The point-of-care MRI also has the advantage of sparing patients from exposure to ionizing radiation. Alfred Health is committed to providing state-of-the-art care with the first institution in Australia to provide point-of-care MRI, CT, US, and X-ray in our ICU,” said Professor Meng Law, Director of Radiology, Alfred Health, Director of integrated Biomedical Research in AI and Neuroimaging, Department of Neuroscience, Monash University.

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The Australian National Imaging Facility (NIF) selected the Swoop system as an industry partner in a two-million-dollar project to provide state-of-the-art imaging capability for the Australian research community. NIF’s grid of imaging facilities is distributed across Australia, offering a range of leading-edge imaging instrumentation and expertise in the optimal use of imaging technology to the Australian research community. “The Hyperfine scanners provide point-of-care imaging that has the potential to transform access to MRI in rural and remote communities in Australia. Our project aims to expand their applications using artificial intelligence and improve accessibility to this potentially life-saving medical imaging technology for patients living in rural and remote areas,” said Professor Gary Egan, Director of Monash Biomedical Imaging in Melbourne, Australia.

The Swoop Portable MR Imaging System is being used worldwide to address some limitations of current imaging technologies and make MRI more accessible. Hyperfine designed the system to wheel directly to a patient’s bedside, plug into a standard electrical wall outlet, and be controlled by an off-the-shelf tablet. With the Swoop system, rapid MR imaging is now available at the point of care, potentially allowing physicians to diagnose and determine treatment for patients regardless of income or location.

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