Hyperfine reports Penn Medicine is among the very first medical centers to use this FDA 510(k)-pending system. In addition to assessing the feasibility of imaging patients with the new device, the Penn Medicine team will be evaluating the Hyperfine system’s diagnostic performance compared to current high field MRI machines and computed tomography (CT) scanners.
Hydrocephalus is a medical condition in which an abnormal buildup of cerebrospinal fluid (CSF) causes the fluid-filled spaces of the brain to become enlarged. This can lead to headaches, dizziness, cognitive impairment, gait disturbances, and in severe cases, even brain herniation or death.
“To treat this condition, an intracranial tube or shunt may be inserted to drain the CSF. Sometimes shunts need to be adjusted or replaced, which requires routine clinical CT or MRI for monitoring,” said Joel Stein, MD, Ph.D., a neuroradiologist and Assistant Professor of Radiology in the Perelman School of Medicine at the University of Pennsylvania. “We want to see if this kind of device can provide a simple, safe and cost-effective way to follow such patients in a physician’s office. Due to the lack of ionizing radiation and open design, it may be particularly useful for children as well as older people.”
The Hyperfine point-of-care (POC) device represents multiple innovations in MRI design, architecture and workflow. It is highly portable and wheels directly to the patient’s bedside, plugs into a standard electrical wall outlet, and is controlled via an iPad®. Hyperfine’s system was developed over the last five years with the goal of making MRI accessible anytime, anywhere, to any patient.
“Hyperfine was founded to increase access to MRI, to move MRI directly to the frontlines of clinical care. Along the way, we have overcome many engineering, physics, and design challenges, and now, together with Penn Medicine, we are excited and honored to see how these efforts can translate to innovative care and greater access for patients,” said Jonathan Rothberg, Ph.D., founder, and chairman of Hyperfine Research.
Hyperfine is introducing its POC MRI system to the broader radiologist community at the Radiological Society of North America (RSNA) meeting on December 1 through December 5 at McCormick Place in Chicago, IL, Booth 7765 (North Hall). Hyperfine’s device is currently 510(k)-pending and not available for sale in the U.S.