Hyperfine, Inc. Receives FDA Clearance for Updated AI-powered Software with Improved Image Quality for All Swoop® System Sequences

10 October 2023

Hyperfine, Inc. (Nasdaq: HYPR), a pioneering medical device company known for revolutionizing brain imaging with the world's first FDA-cleared portable magnetic resonance brain imaging system, the Swoop® system, has announced the FDA clearance of an updated software. This latest software iteration, built on a robust AI foundation, introduces enhancements to the image quality of the Swoop® system's diffusion-weighted imaging (DWI) sequence.

With this software update, Hyperfine, Inc. is extending the AI denoising capabilities of the Swoop® system by integrating advanced image post-processing into the DWI sequence. Previously, this AI feature was available for the system's other sequences, including T1, T2, and FLAIR. Denoising contributes to sharper images, potentially aiding healthcare professionals in making more precise diagnoses, treatments, and monitoring decisions for patients undergoing brain imaging.

Tom Teisseyre, Chief Operating Officer of Hyperfine, Inc., expressed, "Our mission is to make brain imaging more accessible, clinically relevant, and actionable. We consistently advance across all imaging sequences, and with this significant update, we now incorporate deep learning into our DWI sequence. These enhancements will play a vital role in elevating image quality for healthcare professionals working in time-sensitive situations."

Maria Sainz, President and CEO of Hyperfine, Inc., commented, "Achieving our eighth FDA software clearance for the Swoop® system within three years underscores our unwavering commitment to innovation and continuous improvement. Our primary focus remains on delivering high-quality brain imaging to a broader range of healthcare providers and patients across various care settings. This goes beyond mere milestones; it's about reshaping patient care, empowering clinicians, and advancing the field of brain imaging."

The updated Swoop® system software will be gradually rolled out by Hyperfine, Inc. in the upcoming months.

 

Source: businesswire.com