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Hyperfine Announces Expansion into Australia and New Zealand with Medical Device Registration and Notification

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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