Medical device corporation Hyperfine has commenced the acute ischemic stroke detection with portable magnetic resonance (ACTION PMR) multi-site observational study using the Swoop system.
Swoop is claimed to be the world’s first portable magnetic resonance brain imaging system approved by the US Food and Drug Administration (FDA).
The system received CE certification in the European Union and UKCA certification in the UK. It also received approval in various countries such as Australia, New Zealand and Canada.
The international, prospective trial is intended to assess the integration of brain imaging with Swoop within the workflow of stroke diagnosis and treatment.
It aims to utilise point-of-care brain imaging for detecting strokes and saving viable brain tissue.
The study will be led by four investigators from major institutions.
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The investigators include Dr Taylor Kimberly from the Massachusetts General Hospital, Dr Vivien Lee from the Ohio State University Wexner Medical Center, Dr Keith Muir from the University of Glasgow and Dr Adnan Siddiqui from the University at Buffalo.
Hyperfine president and CEO Maria Sainz said: “Our ambition is to enable innovative and readily accessible brain imaging solutions that enhance the chances of recovery for every patient.
“ACTION PMR is an important project for us and we are honoured to be working with our distinguished clinical investigators and stroke advisors to navigate the challenges and opportunities in stroke care and formulate the role the Swoop system can play in acute stroke workflow.”
The company has also established an advisory board, including stroke experts, as part of its cute ischemic stroke initiatives.