Healthcare technology company Hyperfine announced that the FDA cleared its Optive AI software for its Swoop system, an AI-powered portable MRI system for the brain.
The software upgrade marks the tenth-generation release of Optive AI.
The Swoop system in an intensive care unit enables timely brain imaging at the point of care while also eliminating the need to transport critically ill patients to radiology.
According to the company, Optive AI software “enhances every stage of the imaging process, from noise cancellation and image acquisition to reconstruction and post-processing.”
The aim is to produce brain images with greater clarity and uniformity, and sharper anatomical detail.
Rollout of the Optive AI software is scheduled for the third quarter of this year.
“This software release marks the beginning of a transformative era for Hyperfine,” Rafael O’Halloran, vice president of technology at Hyperfine, said in a statement.
“The advanced AI algorithms integrated into our new software platform dramatically elevate image quality at ultra-low field strength, enabling more confident diagnoses at the point of care.”
THE LARGER TREND
In March, Hyperfine collaborated with NVIDIA to leverage NVIDIA’s AI and rapid computing to strengthen Hyperfine’s portable imaging technology, the Swoop system.
The alliance between Hyperfine and NVIDIA focuses on advancing AI-powered image reconstruction and integrating real-time clinical decision support into portable MRI workflows.
By leveraging NVIDIA’s training and inference tools, such as NVIDIA DALI and MONAI, the alliance aims to enhance the Swoop system’s image quality, reduce scan times and enable more rapid diagnoses.
In April, Hyperfine enrolled patients in the NEURO PMR (Neurological Evaluation in the Office with Portable MRI) study.
The NEURO PMR study is the first multi-center, prospective observational study comparing portable ultra-low-field MRI with conventional high-field MRI in terms of pathology findings, clinical utility and patient experience.
In 2024, Hyperfine expanded its commercial operations through agreements with distributors to support commercial expansion of the Swoop system into Turkey, Israel and Saudi Arabia.
The distribution agreements aimed to strengthen the company’s global expansion strategy, broadening access to MR brain imaging in regions with large populations, low MRI penetration and significant unmet healthcare needs.
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