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Embrace® Neonatal MRI System Receives Preapproval
of Manufacturer’s Certification (OPM) from California HCAI
Certification Helps Pave the Way for California Hospitals to Install Innovative Point of Care MRI Inside the NICU
Nashville, TN, October 3, 2022: Aspect Imaging, Ltd., global manufacturer of high performance, compact imaging solutions designed for clinical and preclinical applications, applied for and received Preapproval of Manufacturer’s Certification (OPM-0653) from the California Department of Health Care Access and Information (HCAI) for the company’s breakthrough, point-of-care Embrace® Neonatal MRI System. According to the certification, the patient-focused, point-of-care Embrace® MRI is in compliance with the latest California Health and Safety Code as well as the manufacturer’s certification provisions of the CBC and ASCE for seismic design of supports and attachments for nonstructural components.
“We are pleased to know that the Embrace® Neonatal MRI System meets the seismic design requirements for health facilities construction throughout the state of California, says Wendy Slatery, chief commercial officer for Aspect Imaging, Ltd. “This preapproval certification (OPM-0653) means one less hurdle for healthcare architects, designers and hospital facilities managers to include the Embrace® system as part of their NICU construction plans. In addition to providing an innovative, point of care imaging solution, specifically
designed for neonatal patients inside the NICU, we are committed to taking the necessary steps to help mitigate safety and construction challenges associated with equipment installation.”
With the OPM-0653 certification, healthcare architecture/design firms and healthcare systems alike, throughout the state of California, can proceed to specify this breakthrough MRI system as part of a new construction or renovation project.
The HCAI Preapproval of Manufacturer’s Certification (OPM), which is offered by the California Department of Health Care Access and Information, is a voluntary program for review and preapproval of seismic design of supports and attachments for nonstructural components to be used in health facilities construction in California. For more information, visit https://hcai.ca.gov/.
Prior to receiving statewide preapproval certification in California, Aspect Imaging obtained similar certification in 2021 from the Florida Agency of Health Care Administration (AHCA), with the installation of the Embrace® Neonatal MRI System inside the newly constructed Bowery Family Critical Care Tower of Wolfson Children’s Hospital, Jacksonsville, Florida.
“We recognize our responsibility as an equipment manufacturer to acquire the necessary certifications that help to remove obstacles for healthcare architects, engineers, and facility designers,” explains Slatery. “We will continue to pursue and obtain certifications in other states, where required, to help ensure greater access to point of care imaging for earlier diagnosis and treatment of even the most vulnerable NICU patients.”
About the Embrace® Neonatal MRI System
The Embrace® Neonatal MRI System is transforming neonatal care at the point of care, by enabling greater access to the information only available through MRI for those NICU patients who need it most. The patient-focused Embrace® features a small footprint and is uniquely designed to fit perfectly in an existing or newly constructed NICU. By eliminating the stress, risks, complexity and time often associated with transporting vulnerable neonates to the Radiology department for scanning, clinicians can access the critical data needed to make more confident care decisions, while NICU patients remain safe and comfortable in their care environment.
About Aspect Imaging Ltd.
Aspect Imaging is a world leader in the design and development of innovative, compact magnetic resonance imaging (MRI) systems for use in research and clinical applications. Our breakthrough technology in compact, high-performance, permanent magnets — including the Embrace® Neonatal MRI System, the first FDA-cleared, CE-marked MRI system designed specifically for use with premature and critically-ill patients inside the Neonatal Intensive Care Unit — offers disruptive MRI solutions designed to address unmet needs in research and medical applications, providing quality, high-resolution imaging for the benchtop and at the point-of-care.
For more information about the Embrace® Neonatal MRI System, visit embracemri.com or contact Wendy Slatery at wslatery@aspectimaging.com.
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About Aspect Imaging:
Aspect Imaging is a global leader in the design and development of compact, MR imaging systems for Pre-Clinical and Medical applications. Through state-of-the-art technology, Aspect Imaging offers innovative point-of-care MRI solutions, including the Embrace® Neonatal MRI System, which is designed to facilitate enhanced patient-centered diagnostic capabilities inside the NICU.
For more information, visit our website at www.aspectimaging.com.