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In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) expanded the FDA's authorities and strengthened the Agency's ability to safeguard and advance public health. Among other authorities, FDASIA permitted FDA to publish regulations establishing a Unique Device Identification (UDI) system for medical devices.
MIL-STD-130, "Identification Marking of U.S. Military Property," is a specification that describes markings required on items sold to the Department of Defense (DoD), including the addition, in about 2005, of UII (unique item identifier) Data Matrix machine-readable information (MRI) requirements.
Article 10 of the directive sets out the scope of the derogation for MRI, stating that the exposure limits may be exceeded during "the installation, testing, use, development, maintenance of or research related to magnetic resonance imaging (MRI) equipment for patients in the health sector, provided that certain conditions are met."
Medical device maker Medtronic announced in a press release yesterday that it has won FDA regulatory approval for its Advisa DR MRI SureScan pacemaker. The Advisa is Medtronic's second MR ...
The FDA Modernization Act of 1997 was instituted to improve the regulatory process for medical products. Section 112 of the Act gives explicit authority to give expedited approval for drugs that treat serious conditions as long as it has shown to have an effect on a surrogate end-point that reasonably indicates a clinical benefit.
Resolution: Medical MRI resolution is typically about 1 mm; the desired resolution of MRM is 100 μm or smaller to 10 μm, comparable with histology. Specimen size: Medical MRI machines are designed so that a patient may fit inside. MRM chambers are usually small, typically less than 1 cm 3 for the imaging of rats, mice and rodents. BrukerBio ...
Gadobutrol is a medicinal product used in diagnostic magnetic resonance imaging (MRI) in adults and children. It provides contrast enhancement during cranial, spinal, breast, or other investigations. In the central nervous system, Gadobutrol works by highlighting any areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity.
Schematic diagram of a conventional MRI scanner. Not shown are the electronic control systems and service plant (chillers, etc.) these are usually installed in a seperate room. 19:42, 6 January 2007: 2,980 × 4,213 (34 KB) ChumpusRex: Schematic diagram of a conventional MRI scanner.