Medical device company Hyperfine has secured the US Food and Drug Administration (FDA) 510(k) clearance for the latest software update of its Swoop portable magnetic resonance imaging (MRI) system.
The FDA-cleared MRI System is designed to provide neuroimaging at the point of care.
The updated software is said to considerably improve diffusion-weighted imaging (DWI) and image quality.
US-based Hyperfine said that it increased the signal-to-noise ratio (SNR) for the DWI sequence by 42% in comparison to the previous software version.
The medical device company said that the improvement in SNR along with more compensation for subtle patient motion can offer improved image quality for the DWI sequence.
Additionally, the new software version offers improved image homogeneity throughout all sequences, Hyperfine added.
Hyperfine chief product officer Tom Teisseyre said: “We are ecstatic about the FDA clearance of our latest software.
“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.”
Hyperfine said that the updated Swoop system software is anticipated to be introduced in the market this month.
Initially, the Swoop system received FDA clearance in 2020 as a bedside MRI device. It was intended to generate images of the internal structure of the head where a full diagnostic examination is not clinically possible.
Hyperfine senior medical director Edmond Knopp said: “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.”
In June last year, the company completed the registration and notification of its Swoop System in Australia and New Zealand. It will enable the sale of the system and FDA-cleared reconstruction software in both countries.
