Hyperfine has announced that it has received US Food and Drug Administration (FDA) clearance for a new multi-direction diffusion-weighted imaging (DWI) software sequence within its artificial intelligence (AI)-powered, portable magnetic resonance imaging (MRI) Swoop system.
This advancement delivers “substantially improved” image quality and diagnostic confidence for stroke detection, expanding the Swoop system’s clinical capabilities in acute neurological care, according to a press release from the company.
The new DWI sequence acquires and averages signals from multiple directions, similar to the method used in high-field MRI scanners, with the goal of producing cleaner, more consistent images. The multi-direction acquisition method minimises factors that can obscure stroke pathology, resulting in clearer lesion visualisation that translates to improved sensitivity for detecting smaller strokes and greater specificity in confidently distinguishing true infarcts—critical factors for diagnostic accuracy, Hyperfine claims.
The company says its existing single-direction DWI sequence remains available and provides a time advantage for extremely urgent situations where rapid imaging is essential to meet stroke treatment protocols, and both DWI sequences are available for all models of the Swoop system.
“From a clinical perspective, adding this multi-direction DWI sequence is a gamechanger for stroke imaging with portable MRI,” said Edmond Knopp, Hyperfine’s chief medical officer. “The ability to more confidently detect smaller stroke lesions is particularly valuable for critical care settings, including cardiac ICUs [intensive care units], post-procedure follow-up imaging, and baseline assessments for emergency department triage and discharge decisions. Meanwhile, our single-direction DWI is faster and aligns well with stroke protocols, which is a real advantage in ultra-urgent situations, such as when clinicians need to determine whether to administer thrombolytic therapy.”
“Our multi-direction DWI sequence is the first of many advancements planned for our Optive AI software—cleared six months after the initial clearance—and represents a pivotal milestone in expanding the Swoop system’s role in stroke care,” added Maria Sainz, president and chief executive officer (CEO) of Hyperfine. “This enhanced imaging capability strengthens our clinical utility for stroke triage by delivering the high-quality diffusion imaging that clinicians need, coupled with the portability and accessibility that define the Swoop system. Hyperfine is well poised to capture significant opportunity in stroke diagnosis and expand our presence across multiple hospital care settings.”
