FDA okays updated software for Hyperfine’s Swoop Portable MRI

Hyperfine has gained U.S. Food and Drug Administration (FDA) 510(k) clearance of the latest update of its Swoop portable MRI system software.

The updated software improves the device’s diffusion-weighted imaging (DWI). The company says it achieved a 42% increase in the signal-to-noise ratio (SNR) compared to the previous software version. The SNR increase plus more robust compensation for patient motion yields improved image quality for the DWI sequence. The updated software also offers enhanced image uniformity for all sequences.

The DWI sequence in MRI provides images useful to diagnose a wide range of neurological conditions. DWI imaging is crucial to monitor stroke progression and evaluate primary treatment effectiveness.

“We are committed to continuously improving the provider and patient experience with the Swoop system, with the goal of enabling more-confident patient diagnosis in the neurocritical care setting. With this latest software, Swoop system images provide increasingly valuable diagnostic images that can aid clinicians in caring for neurocritical patients,” Edmond Knopp, M.D., senior medical director of Hyperfine told the press.

“We are ecstatic about the FDA clearance of our latest software,” added Tom Teisseyre, chief product officer of Hyperfine. “Our focus remains on enhancing the image quality of all sequences through better image acquisition and advanced AI-powered image reconstruction. I take immense pride in the considerable image quality that our team has achieved across the Swoop system’s T1, T2, FLAIR, and DWI sequences and delivering that to the point of care.”

The updated Swoop system software is expected to roll out in March 2023. The Swoop portable MRI system eared CE mark clearance last week. Medical Product Outsourcing