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Tag: FDA

Home » News » Tag: FDA
TechTalk Podcast Episode 3: Artificial Intelligence in the New Era of Smarter Food Safety

TechTalk Podcast Episode 3: Artificial Intelligence in the New Era of Smarter Food Safety

(03/21/2022)

The third installment of FDA’s new podcast series on technology and food safety focuses on artificial intelligence (AI) and its potential to advance food safety. This quarterly podcast explores the …

FDA Collaborates with Health Canada and UK’s MHRA to Foster Good Machine Learning Practice

FDA Collaborates with Health Canada and UK’s MHRA to Foster Good Machine Learning Practice

(10/27/2021)
International / News / Regulation / Trustworthy AI

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 …

FDA Virtual Public Workshop on Transparency of Artificial Intelligence/Machine Learning-enabled Medical Devices

FDA Virtual Public Workshop on Transparency of Artificial Intelligence/Machine Learning-enabled Medical Devices

(10/14/2021)

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 …

11th Annual Global Summit on Regulatory Science – Day 2 (Artificial Intelligence and Machine Learning)

11th Annual Global Summit on Regulatory Science – Day 2 (Artificial Intelligence and Machine Learning)

(10/05/2021)

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 …

Virtual Workshop on Next-Generation Sequencing and Radiomics

Virtual Workshop on Next-Generation Sequencing and Radiomics

(09/29/2021)

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 partners with Aidar Health, Inc. to develop and validate machine learning algorithm for rapid health assessment and patient triage

BARDA partners with Aidar Health, Inc. to develop and validate machine learning algorithm for rapid health assessment and patient triage

(09/27/2021)
Applications / News / Partnership / R&D

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 …

FDA Authorizes Software that Can Help Identify Prostate Cancer

(09/21/2021)
Applications / News

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 …

FDA Authorizes Marketing of Diagnostic Aid for Autism Spectrum Disorder

FDA Authorizes Marketing of Diagnostic Aid for Autism Spectrum Disorder

(06/02/2021)
Applications / News

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 …

FDA Authorizes Marketing of First Device that Uses Artificial Intelligence to Help Detect Potential Signs of Colon Cancer

FDA Authorizes Marketing of First Device that Uses Artificial Intelligence to Help Detect Potential Signs of Colon Cancer

(04/09/2021)
Applications / News

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 …

FDA Artificial Intelligence and Machine Learning in Software as a Medical Device

FDA Artificial Intelligence and Machine Learning in Software as a Medical Device

(01/12/2021)
News / Regulation / Strategy

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 …

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