MRI device company Hyperfine Research Inc said on Monday that it plans the launch of the clinical research study of the world's first portable, low-cost magnetic resonance imaging (MRI) system in partnership with Penn Medicine.
Under the collaboration, Penn Medicine will examine the efficacy of the Hyperfine device in the care of patients with hydrocephalus, 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.
In addition to assessing the feasibility of imaging patients with the new FDA 510(k)-pending system Hyperfine device, Penn Medicine will evaluate the Hyperfine system's diagnostic performance versus current high field MRI machines and computed tomography (CT) scanners.
The Hyperfine point-of-care (POC) device is highly portable and wheels directly to the patient's bedside, plugs into a standard electrical wall outlet and is controlled via an iPad. The system was developed with the goal of making MRI accessible anytime, anywhere, to any patient.
Additionally, Hyperfine is introducing its POC MRI system to the broader radiologist community at the Radiological Society of North America (RSNA) meeting on 1 December through 5 December at McCormick Place in Chicago, IL, Booth 7765 (North Hall).
Renova Pharmaceuticals launches first three US generic products
FDA grants Priority Review to Genentech's Enspryng for MOGAD
CordenPharma increases aseptic fill-finish capacity
Biophytis expands BIO101 obesity study to assess weight regain
THX Pharma secures European patent for Batten-1 in juvenile Batten disease
Etcamah–CDK4/6 inhibitor combination approved in US for ESR1-mutated HR-positive breast cancer
Guardant Health wins FDA approval for Guardant360 CDx in advanced breast cancer
Agilent launches S540MD slide scanner system in US
Kali Therapeutics' KT501 Investigational New Drug application cleared by US FDA
AstraZeneca completes global licence agreement for Zegfrovy
NeuroSense reveals strategy to advance PrimeC toward potential ALS approval
UCB agrees with US government to lower medicine costs and strengthen US manufacturing
Karyopharm seeks accelerated FDA approval for selinexor–ruxolitinib in myelofibrosis