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The U.S. Food and Drug Administration has kicked off the third phase of the Artificial Intelligence (AI) Imported Seafood Pilot program, which uses AI and machine learning (ML) to strengthen …
The U.S. Food and Drug Administration (FDA) is reminding health care providers about the intended use of radiological computer-aided triage and notification (CADt) devices for intracranial large vessel occlusion (LVO). …
Today, the U.S. Food and Drug Administration, Health Canada and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) jointly issued the “Good Machine Learning Practice for Medical Device …
BARDA is collaborating with Aidar Health, Inc. to develop and validate the company’s Aidar COVID-19 decompensation index (AIDI), a new early warning system that uses MouthLab, a U.S. Food and …
Today, the U.S. Food and Drug Administration authorized marketing of software to assist medical professionals who examine body tissues (pathologists) in the detection of areas that are suspicious for cancer …
Today, the U.S. Food and Drug Administration authorized marketing of a device to help diagnose autism spectrum disorder (ASD). The Cognoa ASD Diagnosis Aid is a machine learning-based software intended …
Today, the U.S. Food and Drug Administration authorized marketing of the GI Genius, the first device that uses artificial intelligence (AI) based on machine learning to assist clinicians in detecting …
Artificial intelligence and machine learning technologies have the potential to transform health care by deriving new and important insights from the vast amount of data generated during the delivery of …
Today, 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 …
Today, the U.S. Food and Drug Administration authorized marketing of software to assist medical professionals in the acquisition of cardiac ultrasound, or echocardiography, images. The software, called Caption Guidance, is …
