FDA

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The U.S. Food and Drug Administration (#FDA) approved #Aduhelm (#aducanumab) for the treatment of #Alzheimer’s, a debilitating disease affecting 6.2 million Americans. Aduhelm was approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments.
News | PET Imaging

FDA Grants Accelerated Approval for Alzheimer’s Drug Aduhelm

June 7, 2021 — The U.S. Food and Drug Administration (FDA) approved Aduhelm (aducanumab) for the treatment of Alzheimer ...

Time June 07, 2021
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The U.S. Food and Drug Administration (FDA) issued this final guidance: Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.
News | Magnetic Resonance Imaging (MRI)

FDA Issues Final Guidance on Medical Devices in the MR Environment

May 21, 2021 — The U.S. Food and Drug Administration (FDA) issued this final guidance: Testing and Labeling Medical ...

Time May 21, 2021
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After May 30, 2021, the U.S. Food and Drug Administration (FDA) will no longer accept Quality in 510(k) Review Files.  Companies should consider using the electronic Submission Template and Resource (eSTAR).
News | Radiology Imaging

FDA Is Concluding the Quality in 510(k) Review Program Pilot

April 26, 2021 — After May 30, 2021, the U.S. Food and Drug Administration (FDA) will no longer accept Quality in 510(k) ...

Time April 26, 2021
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The U.S. Food and Drug Administration (#FDA) authorized marketing of #Medtronic's #GIGenius, the first device that uses #artificialintelligence (#AI) based on #machinelearning to assist #clinicians in detecting #lesions (such as #polyps or suspected tumors) in the #colon in real time during a c#olonoscopy.
News | Artificial Intelligence

FDA Authorizes Marketing of First Device that Uses AI to Help Detect ...

April 12, 2021 — The U.S. Food and Drug Administration (FDA) authorized marketing of Medtronic's GI Genius, the first ...

Time April 12, 2021
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#Q-Collar The U.S. Food and Drug Administration authorized marketing of a new device intended to be worn around the neck of athletes aged 13 years and older during sports activities to aid in the protection of the brain from the effects associated with repetitive sub-concussive head impacts.
News | Magnetic Resonance Imaging (MRI)

MRI Plays Role in Developing Novel Device to Help Protect Athletes’ ...

February 26, 2021 — The U.S. Food and Drug Administration authorized marketing of a new device intended to be worn ...

Time February 26, 2021
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The U.S. Food and Drug Administration released the agency's first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. This action plan describes a multi-pronged approach to advance the Agency's oversight of AI/ML-based medical software.
News | Artificial Intelligence

FDA Releases AI/Machine Learning Action Plan

January 12, 2021 — The U.S. Food and Drug Administration released the agency's first Artificial Intelligence/Machine ...

Time January 12, 2021
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The FDA is monitoring the potential impact of viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant, on authorized SARS-CoV-2 molecular tests
News | Coronavirus (COVID-19)

FDA Issues Alert Regarding SARS-CoV-2 Viral Mutation to Healthcare ...

January 8, 2021 — The U.S. Food and Drug Administration is alerting clinical laboratory staff and healthcare providers ...

Time January 08, 2021
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The FDA recently received a report that a patient’s face was burned from the metal in a face mask worn during an MRI, and reminds patients and providers that patients should not wear any metal during an MRI #COVID19 #pandemic
News | Magnetic Resonance Imaging (MRI)

FDA Reminds Patients to Wear COVID Face Masks with No Metal During MRI ...

December 7, 2020 — The U.S. Food and Drug Administration (FDA) is informing patients and health care providers that ...

Time December 07, 2020
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Guidance for mammography facilities, state MQSA contract partners, FDA-approved MQSA accreditation bodies and Food and Drug Administration staff
News | Mammography

FDA Issues Guidance on Enforcement Policy for the Quality Standards of ...

December 4, 2020 — Today, the U.S. Food and Drug Administration (FDA) issued an immediately in effect guidance, Enforcem ...

Time December 04, 2020
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The FDA Center for Devices and Radiological Health's COVID-19 response by the numbers between January 1 and September 18, 2020.
News | Coronavirus (COVID-19)

FDA Commissioner Addresses Center for Devices and Radiological Health ...

September 29, 2020 — On September 28, FDA Commissioner of Food and Drugs Stephen M. Hahn, M.D., issued a statement ...

Time September 29, 2020
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