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The Food and Drug Administration (FDA) is announcing a virtual public workshop on transparency of Artificial Intelligence/Machine Learning (AI/ML)-enabled medical devices to patients, caregivers, and providers. The role of transparency …
Day 2─Tuesday, October 5: Artificial Intelligence and Machine Learning The program starts with a keynote presentation by Stephen Quest (General Director at Joint Research Center, EU), followed by six international …
The National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) Joint Leadership Council Next-Generation Sequencing and Radiomics Working Group is hosting a virtual workshop on resource …
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 …
