Hyperfine has received U.S. Food and Drug Administration (FDA) clearance for a new multi-direction diffusion-weighted imaging (DWI) software sequence for its Swoop AI-powered, portable MRI system for the brain.

The new DWI sequence acquires and averages signals from multiple directions—similar to the method used in high-field MRI scanners—to generate clean, consistent images. The multi-direction acquisition method, according to Hyperfine, minimizes factors that can obscure stroke pathology to allow clearer lesion visualization that translates into more sensitivity to detect strokes and more specificity in distinguishing true infarcts.

The company’s existing single-direction DWI sequence is still available and offers a time advantage for urgent situations where rapid imaging is necessary to meet stroke treatment protocols. Both DWI sequences are available for all models of the Swoop MRI.

“From a clinical perspective, adding this multi-direction DWI sequence is a game-changer 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, 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.”

This advancement, the company said, provides significantly better image quality and diagnostic confidence for stroke detection. It also signals a substantial expansion of Swoop’s clinical capabilities in acute neurological care.

“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,” said Maria Sainz, Hyperfine’s president and CEO. “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.”

Last month, the company received a Gates Foundation grant of $3.7 million to strengthen the company’s initiatives to improve global brain health in underserved settings.