• Regulatory NewsRegulatory News

    FDA finalizes brain-computer interface guidance, issues draft for glycemic control devices

    The US Food and Drug Administration (FDA) has issued four medical device-related guidance documents. The new guidances address brain-computer interfaces, considerations in medical device design for the magnetic resonance imaging environment, clinical studies for devices to improve glycemic control and premarket notification submissions for peripheral atherectomy devices.   The four documents, one in draft and three in final form, were part of a larger swath of guidance...
  • Regulatory NewsRegulatory News

    FDA Clears First MRI Meant for Use in NICUs

    The US Food and Drug Administration (FDA) on Thursday announced it has cleared the first magnetic resonance imaging (MRI) device intended to be used on newborns in neonatal intensive care units (NICUs). FDA says the device, Aspect Imaging's Embrace Neonatal MRI System, was cleared via the 510(k) pathway specifically for taking images of newborn's heads, and can be used on newborns whose heads measure up to 38 centimeters in circumference and weigh between 1 and 4.5 kilog...
  • Regulatory NewsRegulatory News

    FDA to Replace 17-Year-Old Guidance for MRI Premarket Notifications

    The US Food and Drug Administration (FDA) is seeking input as it begins to draft a new guidance intended to help makers of magnetic resonance diagnostic devices (MRDDs) complete premarket notification 510(k) applications. Background After scientific advances in the 1970s led to the first images produced using magnetic resonance (MR), clinical interest in the technology grew rapidly. In the 1980s, these advances made magnetic resonance imaging (MRI) useful for clin...
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    FDA Dials in on MRI Safety of Passive Implantable Medical Devices

    For the second time in a year, the US Food and Drug Administration (FDA) has released new guidance intended to ensure the safety of implanted medical devices from magnetic resonance imaging (MRI) devices. Background In medicine, the context of a product's use is very often the difference between a product that cures and one that kills. For example, a medicine given in the wrong dose or to the wrong patient might leave someone injured or dead. But for medical devices, t...
  • Feature ArticlesFeature Articles

    Magnetic Resonance Safety Testing and Labeling for Devices

    Traditionally, all Magnetic Resonance (MR) scanner systems have included a contraindication for patients with metallic implants. General practice was to not scan patients with implants in ordinary facilities, but only at more-sophisticated MR facilities under carefully monitored and controlled conditions. Since then, Magnetic Resonance Imaging (MRI) has become the standard of care for diagnosing many conditions, such as cancer, neurological diseases and orthopedic disord...
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    Will an MRI Damage my Implant? New FDA Policy Aims to Improve Safety

    Can a medical device be used safely around magnetic resonance imaging equipment? It's not always easy for healthcare providers or patients to know. Now a new final guidance document issued by the US Food and Drug Administration (FDA) recommends that medical device manufacturers test and label their products to ensure that use of their devices doesn't lead to injuries. Guidance Details The guidance, Establishing Safety and Compatibility of Passive Implants in the Magne...
  • FDA Looks to Establish Patient Registry to Assess Risks of Imaging Contrast Agents

    • 17 July 2012
    The US Food and Drug Administration (FDA) has announced its intent to establish a new patient registry to assess the postmarketing risks of several contrast agents used in magnetic resonance imaging and angiography (MRI/MRA). In an 18 July posting in the Federal Register , FDA noted six of the eight gadolinium-based contrast agents (GBCAs) used in MRIs and MRAs are associated with nephrogenic systemic fibrosis (NSF)-a condition that causes excessive connective tissue ...