Portable MR manufacturer Hyperfine has nabbed FDA clearance for its upgraded AI-powered software, part of its portable, point-of-care MR scanner, Swoop, the first FDA-cleared portable MR scanner for brain imaging.

The software increases signal-to-noise ratio for better diffusion-weighting imaging sequence (DWI) quality, along with the field of view by 10% for T1, T2 and FLAIR sequences to match the sequences' 20 cm field of views.

DWI provides molecular functional and micro-architecture information to accompany anatomical data collected during MR scans.
“The improved image quality more clearly displays underlying brain structure, further accentuating diffusion positivity and potentially increasing confidence in image interpretation and clinical decision-making,” said Dr. Edmond Knopp, senior medical director of Hyperfine Inc., in a statement.

Swoop
Swoop provides neuroimaging at patient bedsides, reduces waiting and transport time, and adverse events associated with transport.

It has a .064 Tesla magnet — significantly lower than that of a standard scanner — requires no shielding, and was designed with the nearly 90% of the world lacking access to MR in mind.

The system was cleared by the FDA and rolled out in 2020, with the company saying that it is 20 times cheaper, 10 times lighter and consumes 35 times less power than fixed MR scanners.

More upgrades
Hyperfine previously expanded the system’s field of view to look deeper within the brain and collect more diagnostic information. It also improved its DWI sequence image quality twice before and released its T1 Standard and Fast T2 sequences in the last twelve months.

In the last year, Hyperfine has received FDA clearance for five hardware and software improvements. One is its Brain Insight software, which uses automated AI tools to extract and create quantitative biomarker information. Another was its deep learning, advanced image reconstruction technology, in 2021, for producing crisper T1, T2 and FLAIR images.

Efficacy
To date, 100 Swoop systems have been installed globally, and twenty peer-reviewed clinical publications have utilized Swoop system data.

A recent study from Yale–New Haven Hospital was presented at the 2023 International Stroke Conference in Dallas in February 2023. It involved bedside portable MR imaging following mechanical thrombectomy procedures in stroke patients. Ultralow-field pMR established a post-treatment baseline for post-thrombectomy stroke patients to evaluate the impact of potential changes in blood pressure and heart rate affecting ongoing brain injury. The lack of imaging following mechanical thrombectomy can prevent accurate infarction assessments.

Before its release, a preliminary study showed that portable, low-field MR systems were safe and practical for accurately imaging patients at their bedside, with 85 stroke patients receiving this care with Hyperfine within seven days of showing symptoms.

Hyperfine did not respond to HCB News for comment.

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