Michael Barbella, Managing Editor10.16.23
Hyperfine Inc. has finished enrolling patients in the multi-site observational study, HOPE PMR (Portable MRI for Children with Neurological Injury—A Pilot Study using Hydrocephalus as an Index Condition).
Children living with hydrocephalus typically undergo at least two brain scans annually to monitor pressure in their enlarged brain ventricles and identify potential shunt malfunctions. With the aim of exploring a safer, more accessible solution for hydrocephalus patients, the HOPE PMR study is assessing the feasibility of integrating the Swoop system, a brain imaging solution with zero ionizing radiation that is accessible at a child's bedside, into routine inpatient, outpatient, and emergency pediatric care settings. The study used pediatric hydrocephalus as an index condition to assess if Swoop system images can be used to accurately detect shunt malfunctions and assess ventricular size.
"The Swoop system represents a promising shift in brain imaging. We believe it has the potential to improve pediatric hydrocephalus management significantly," Hyperfine Chief Medical Officer/Chief Strategy Officer Dr. Khan Siddiqui said. "The insights gathered from this study will inform the viability of the Swoop system in pediatric healthcare settings and patient care.”
The Swoop system is the world’s first U.S. Food and Drug Administration (FDA)-cleared portable magnetic resonance imaging (MRI) system capable of providing brain imaging at the point of care. The Swoop system received initial FDA clearance in 2020 as a bedside magnetic resonance imaging device for producing images that display the internal structure of the head where a full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The Swoop system has been approved for brain imaging in several countries, including Canada and Australia, has UKCA certification in the United Kingdom, CE certification in the European Union, and is also available in New Zealand.
"With the completion of the enrollment phase of the study, we are now embarking on the critical task of data analysis and academic publication preparation. Our collaboration with Hyperfine, Inc. paves the way for improvements in brain imaging, benefiting this vulnerable patient population," stated Dr. Jeffrey Leonard, chief of Pediatric Neurosurgery at Nationwide Children’s Hospital.
Hydrocephalus, marked by an abnormal buildup of cerebrospinal fluid in the brain, affects more than 1 million Americans. Current treatments, such as the surgical placement of a shunt, experience an alarming failure rate of around 50% within two years of placement,1 highlighting a significant unmet need for improved solutions. Although magnetic resonance imaging (MRI) is the preferred scanning modality due to its absence of ionizing radiation, practical constraints often limit its use. When MRI is unavailable, care providers must resort to computerized tomography (CT) scans, which carry notable risks. Published research indicates a single pediatric head CT scan could double the risk of radiation-associated malignancy.2
Hyperfine Inc. aims to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging and data solutions. Founded by Dr. Jonathan Rothberg in a technology-based incubator called 4Catalyzer, Hyperfine scientists, engineers, and physicists developed the Swoop system out of a passion for redefining brain imaging methodology and the ways in which clinicians can apply accessible diagnostic imaging to patient care. Traditionally, access to costly, stationary, conventional MRI technology can be inconvenient or not available when needed most. The Swoop system brings brain imaging to the patient’s bedside.
References
1 https://www.hydroassoc.org/powerful-hydrocephalus-facts/
2 https://link.springer.com/content/pdf/10.1007/s00381-019-04345-3
Children living with hydrocephalus typically undergo at least two brain scans annually to monitor pressure in their enlarged brain ventricles and identify potential shunt malfunctions. With the aim of exploring a safer, more accessible solution for hydrocephalus patients, the HOPE PMR study is assessing the feasibility of integrating the Swoop system, a brain imaging solution with zero ionizing radiation that is accessible at a child's bedside, into routine inpatient, outpatient, and emergency pediatric care settings. The study used pediatric hydrocephalus as an index condition to assess if Swoop system images can be used to accurately detect shunt malfunctions and assess ventricular size.
"The Swoop system represents a promising shift in brain imaging. We believe it has the potential to improve pediatric hydrocephalus management significantly," Hyperfine Chief Medical Officer/Chief Strategy Officer Dr. Khan Siddiqui said. "The insights gathered from this study will inform the viability of the Swoop system in pediatric healthcare settings and patient care.”
The Swoop system is the world’s first U.S. Food and Drug Administration (FDA)-cleared portable magnetic resonance imaging (MRI) system capable of providing brain imaging at the point of care. The Swoop system received initial FDA clearance in 2020 as a bedside magnetic resonance imaging device for producing images that display the internal structure of the head where a full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The Swoop system has been approved for brain imaging in several countries, including Canada and Australia, has UKCA certification in the United Kingdom, CE certification in the European Union, and is also available in New Zealand.
"With the completion of the enrollment phase of the study, we are now embarking on the critical task of data analysis and academic publication preparation. Our collaboration with Hyperfine, Inc. paves the way for improvements in brain imaging, benefiting this vulnerable patient population," stated Dr. Jeffrey Leonard, chief of Pediatric Neurosurgery at Nationwide Children’s Hospital.
Hydrocephalus, marked by an abnormal buildup of cerebrospinal fluid in the brain, affects more than 1 million Americans. Current treatments, such as the surgical placement of a shunt, experience an alarming failure rate of around 50% within two years of placement,1 highlighting a significant unmet need for improved solutions. Although magnetic resonance imaging (MRI) is the preferred scanning modality due to its absence of ionizing radiation, practical constraints often limit its use. When MRI is unavailable, care providers must resort to computerized tomography (CT) scans, which carry notable risks. Published research indicates a single pediatric head CT scan could double the risk of radiation-associated malignancy.2
Hyperfine Inc. aims to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging and data solutions. Founded by Dr. Jonathan Rothberg in a technology-based incubator called 4Catalyzer, Hyperfine scientists, engineers, and physicists developed the Swoop system out of a passion for redefining brain imaging methodology and the ways in which clinicians can apply accessible diagnostic imaging to patient care. Traditionally, access to costly, stationary, conventional MRI technology can be inconvenient or not available when needed most. The Swoop system brings brain imaging to the patient’s bedside.
References
1 https://www.hydroassoc.org/powerful-hydrocephalus-facts/
2 https://link.springer.com/content/pdf/10.1007/s00381-019-04345-3