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FDA Clears MULTIX Impact C Ceiling-Mounted DR System

Siemens Healthineers has announced the Food and Drug Administration (FDA) clearance of the MULTIX Impact C ceiling-mounted digital radiography (DR) system as well as the MULTIX Impact VA20, a new version of the established floor-mounted parent DR system.

FDA Approves Seno Medical’s Breast Cancer Diagnostic Technology

The Center for Devices and Radiological Health (CDRH) of the U.S. Food & Drug Administration (FDA) has granted Texas-based Seno Medical Instruments Inc.

Philips to Acquire Capsule Technologies Inc.

Royal Philips has signed an agreement to acquire Capsule Technologies Inc., a provider of medical device integration and data technologies for hospitals and healthcare organizations.

HealthMyne Appoints National Oncology Leader to Board of Directors

HealthMyne, a pioneer in applied radiomics, has announced the appointment of Mimi Huizinga, MD, MPH, FACP, to its board of directors.

Study: Portable MRI Successfully Detects Abnormalities at Bedside

A recent study published in the Journal of the American Medical Association Neurology demonstrates for the first time the feasibility of Hyperfine’s Swoop Portable MRI System to obtain bedside neuroimaging for critically ill patients in the intensive care unit settings. Researchers tested the feasibility and demonstrated the clinical utility of the Swoop system in 50 patients, including COVID-19 patients, to assess brain injury and detect abnormalities. These patients were critically ill and presented challenges for transport to conventional MRI suites in the radiology department.

Results from the prospective, observational single-center study, Assessment of Brain Injury Using Portable, Low Field Magnetic Resonance Imaging at the Bedside of Critically Ill Patients, were published on September 8, 2020.

Investigators used the Swoop system from October 2019 through May 2020 and successfully detected abnormal neuroimaging findings at the bedside of patients presenting with ischemic stroke, hemorrhagic stroke, subarachnoid hemorrhage, traumatic brain injury, brain tumor and COVID-19 patients with altered mental status.

According to the study’s senior author, Kevin N. Sheth, MD (Yale University School of Medicine, Department of Neurology), the use of traditional MRI units presents accessibility and transportation challenges in the care of critically ill patients. Furthermore, the highly contagious nature of COVID-19 patients makes bedside MR imaging compelling for infection control protocols.

This study – the first of its kind – demonstrates that deployment of portable MR imaging to patients’ bedsides could fill an important gap for time-sensitive neuroimaging, a cornerstone of triage and treatment pathways.

The study authors conclude, “This experience demonstrates that low-field, portable MRI can be deployed successfully into intensive care settings. This approach may hold promise for portable assessment of neurological injury in other scenarios, including the emergency department, mobile stroke units and resource-limited environments.”

Magnetic Resonance Imaging uses a magnetic field, radio waves and a computer to produce detailed pictures of the body’s internal structures that are clearer, more detailed and more likely in some instances to identify and accurately characterize disease than other imaging methods. However, fixed MRI systems can be inconvenient and inaccessible for providers and patients, particularly when time is critical. Transport to the MR suite demands complicated scheduling coordination, moving patients, and, often, 4 to 6 hour patient backlogs – all which compromise the utility of MRI as a diagnostic tool in time-sensitive settings such as intensive care units and emergency rooms. Furthermore, high capital investments, electrical power needs and significant maintenance requirements present a barrier to adoption across all populations, acutely so for developing countries and rural geographies.

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