FDA recently cleared a software upgrade to Hyperfine’s portable MRI device that enables scenes in under 3 minutes with no ionizing radiation, the Austin, Texas–based company said today.
Hyperfine officials think the advancement could significantly improve the monitoring of hydrocephalus — brain fluid build-up — in children. Pediatric patients may have trouble staying still for an extended period of time in an MRI without sedation. The alternative is to do a CT scan, which includes radiation exposure.
According to Hyperfine, children with hydrocephalus typically receive more than two brain scans per year to ensure that pressure on the brain caused by enlarged ventricles remains normal. There’s also a need to rule out the possibility of shunt malfunctions.
“There is no way to prevent hydrocephalus, and there is no known cure. Young people diagnosed with this life-threatening neurological condition require life-long brain monitoring,” said Dr. Khan Siddiqui, Hyperfine’s chief medical officer.
“Hyperfine designed the Swoop system to bring low-field MRI to the point of care. This unique ability allows young patients to be imaged sooner, avoid harmful ionizing radiation, stay close to their caregivers, and eliminates the intimidating experience of transport and lengthy wait times often associated with traditional MR imaging,” Siddiqui said in a news release.
The software is but another example of innovation in the pediatric device space — which has historically been underserved by medtech developers.
The recently cleared software upgrade includes a T1 Standard sequence optimized for imaging inside the brain and a Fast T2 sequence that provides images that can aid in the assessment of brain ventricles.
Hyperfine unveiled the software upgrade in Austin at HA Connect!, the 17th annual national conference on hydrocephalus.