Since its incorporation in 1996, Cleveland-based SREE Medical Systems has developed and manufactured MRI subsystems and accessories specifically for premature neonates, newborns and infants. Operating as Advanced Imaging Research, the company received the first FDA approval for a newborn-specific MRI imaging device in 2003 and builds, tests and inspects its final assemblies in Cleveland. Its ISO 13485-certified quality system supports collaborations with hospitals, universities and industry on pediatric MRI solutions.
ISO 13485
US FDA 21 CFR 820 Quality System Regulation
Compliance program
Health Canada Medical Devices Regulations SOR/98-282
Compliance program
AAMI/IEC 60601
CSA 22.2
FDA 510(k)
Registration
Health Canada Licensed
Registration
CE
CSA
Quality certification
Weinberg Medical PhysicsFounded in 2008, Weinberg Medical Physics is a medical-device incubator developing compact MRI systems, magnetic-particle technologies and related therapies for clinical use. Based in Rockville, the company combines ultrafast MRI with low-power electropermanent magnets and engineered nanoparticles, turning its work into self-sustaining ventures such as Promaxo, Radialis and Brain Biosciences.ROCKVILLE, MD
Quality Electrodynamics, LLCFounded in 2006 by physicist Dr. Hiroyuki Fujita, Quality Electrodynamics develops and manufactures MRI radiofrequency coils and related medical-imaging technology for diagnostic equipment makers and researchers. The Mayfield Village company became a Canon subsidiary in 2019 while retaining its name and local identity, and its work now includes the patented SureWave™ elastography system for MRI. QED is certified to ISO 13485 and the Medical Device Single Audit Program (MDSAP) by BSI.MAYFIELD VILLAGE, OH
RAPID MR International, LLCFounded in Columbus in 2006 by MR experts from Germany’s RAPID Biomedical, RAPID MR International designs and produces custom magnetic-resonance probeheads and coils for biomedical research and diagnosis. Its made-to-measure work draws on more than 1,200 RF-coil designs used in over 30 countries, spanning human and animal studies from low-field systems to ultra-high-field scanners. The company serves as an independent American link to its German sister company, supporting hospitals, research institutions, pharmaceutical companies and MR equipment manufacturers.COLUMBUS, OH
NEATCap MedicalFounded in late 2015 to bring NICU clinicians’ ideas to market, Bethlehem-based NEATCap Medical manufactures hearing-protection devices for premature infants and other hospitalized newborns. Its DREAMIES products are shaped for neonatal care rather than adapted from standard earmuffs, with one version designed to filter NICU alarms while preserving some human voice and another built for the broader noise of transport and MRI. The team combines more than 60 man-years of NICU clinical experience with over 75 man-years in technology and product development.BETHLEHEM, PA