Hyperfine Research’s magnetic resonance imaging (MRI) system, Lucy is the world’s first point-of-care, bedside MRI device for brain imaging in patients ageing two years and older.

Lucy has been evaluated for general anatomical brain imaging in the cases of headaches, stroke, non-specific muscle weakness, and encephalopathy, as well as studied for the diagnostic imaging of other body parts for the evaluation of spinal cord compression, diabetic foot disease and musculoskeletal trauma.

The company submitted a 510K premarket application to the US Food and Drug Administration (FDA) for the device in July 2019. Lucy received FDA clearance for clinical use, in February 2020.

Hyperfine collaborated with the Yale School of Medicine for the development of the portable MRI technology in October 2019, currently in use in various clinical settings, including the emergency department, paediatrics laboratory, neurointensive care unit (ICU), and neurosurgery.

Lucy MRI system design and features

Lucy MRI system is a patented, portable, affordable open bedside MRI scanner with innovative design and workflow. It is a low-field MRI system equipped with a permanent magnetic system, a power system to power the magnetics system, and a supporting base housing the power system.

The magnetic system generates the field strength of less than or equal to approximately 0.1 Tesla (0.1T). The system has a five-Gauss line with a maximum dimension of less than or equal to 5ft.

The system is 20 times cheaper and consumes 35 times lesser power than the conventional MRI devices. It can be plugged in any standard wall outlet near the patient’s bedside. Weighing 200kg (440lb), Lucy MRI system is ten times lighter than the conventional devices.

Lucy can be moved around the hospital with motorised wheels to reach the patients and prepared for scanning in less than two minutes. Noise suppression techniques allow the system to operate outside the shielded rooms, controlled using a wireless tablet such as an Apple iPad®.

Lucy MRI system development

“The company submitted a 510K premarket application to the US Food and Drug Administration (FDA) for the device in July 2019.”

Yale School of Medicine introduced the Lucy MRI system in the neuro ICU of Yale New Haven Hospital as a part of a two-year clinical trial in collaboration with the American Heart Association.

The clinical trial aims to solve the issues, which prevent the daily use of MRI on unstable neuro ICU patients who cannot be moved to the conventional MRI units, used to scan patients with various brain conditions such as ischemic stroke, tumour, haemorrhages, and oedema. The results were compared with patients’ results collected using the standard MRI systems.

Benefits of Lucy MRI system

In emergency units, accessibility to MRI scans can cause delays in diagnosis and evaluation. The MRI waiting period increases the cost. Lucy MRI system prevents the situation and reaches to the patient wherever required, unlike the standard MRI devices.

The system complements the standard high-field MRI systems. It prevents the isolated feeling in the patients, while scanning, and is for use for even those patients who cannot go to the MRI facilities.

Lucy MRI system utilises magnetic field and radio waves to provide a detailed and sharper image of the internal structure of the body.

Marketing commentary on Hyperfine

Hyperfine Research belongs to the 4Catalyzer family of companies, a health technology incubator.

Hyperfine aims to improve the accessibility of the MRI across the world. It has miniaturised the MRI components to increase its potential and reduce expenses.

During the development of the portable MRI system, Hyperfine carried out thousands of brains examinations in various institutes such as Penn Medicine, Good Samaritan Hospital Long Island, New York-Presbyterian Brooklyn Methodist Hospital, and Brown University.

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