Hyperfine this week announced it received FDA 510(k) clearance for its updated AI-powered software with improved image quality for its Swoop portable MRI system.
The latest software development brings artificial intelligence-based image quality enhancements to Swoop’s diffusion-weighted imaging (DWI) sequence. The software enhances the system’s AI denoising capabilities by incorporating advanced image post-processing into the DWI sequence. The improved denoising allows for crisper images that help clinicians accurately diagnose, treat and monitor patients undergoing brain imaging.
Swoop’s other sequences – T1, T2 and FLAIR – previously benefitted from the AI feature.
“We believe in making brain imaging more accessible, clinically relevant, and actionable. We continue to make meaningful progress across all sequences. With this significant and most recent update, we now incorporate deep learning into our DWI sequence,” chief operating officer Tom Teisseyre said in a news release. “These imaging improvements will serve a critical role in enhancing image quality for healthcare professionals in time-sensitive environments.”
Hyperfine plans to roll out the updated Swoop system software in the coming months.
“Our eighth FDA software clearance in three years for the Swoop® system underscores our relentless drive for innovation and continuous improvement. Our focus remains on providing quality brain imaging to more providers and patients in more sites of care. More than milestones, it’s about reshaping patient care, empowering clinicians, and advancing brain imaging,” CEO and President Maria Sainz said.
