FDA

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AI, including machine learning (ML), spans transformative technologies with the potential to revolutionize healthcare
News | Artificial Intelligence

Artificial Intelligence Paper Outlines FDA’s Approach to Protect ...

March 15, 2024 — Today, the U.S. Food and Drug Administration (FDA) released its “Artificial Intelligence and Medical ...

Time March 15, 2024
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The FDA has identified this as a Class I recall, the most serious type of recall
News | Magnetic Resonance Imaging (MRI)

Philips North America LLC Recalls Panorama 1.0T HFO Due to a Risk of ...

December 20, 2023 — According to the U.S. Food and Drug Administration (FDA), Philips North America LLC is recalling ...

Time December 20, 2023
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Siemens Healthineers has announced the Food and Drug Administration (FDA) clearance of the Magnetom Free.Star
News | Magnetic Resonance Imaging (MRI)

Siemens Healthineers Announces FDA Clearance of Magnetom Free.Star 60 ...

July 5, 2022 — Siemens Healthineers has announced the Food and Drug Administration (FDA) clearance of the Magnetom Free ...

Time July 05, 2022
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Today, the U.S. Food and Drug Administration issued three final guidances to industry regarding cancer clinical trials that parallel the goals of President Biden’s recently announced effort to renew and build upon his 2016 Cancer Moonshot initiative to facilitate continued advancement in cancer prevention, detection, research and patient care.
News | Radiation Oncology

FDA Clinical Trial Guidances Share Biden Administration’s Goals for ...

March 1, 2022 — Today, the U.S. Food and Drug Administration issued three final guidances to industry regarding cancer ...

Time March 01, 2022
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Today, as part of the U.S. Food and Drug Administration’s continued commitment to protect and promote the health of all women, the Center for Devices and Radiological Health (CDRH) is sharing its Health of Women Program Strategic Plan. CDRH initially issued a proposed strategic plan in September 2019 and has considered public feedback to inform this strategic plan, which lays out the framework to further the FDA’s mission by protecting and promoting the health of women, strengthening regulatory science, and
News | Women's Health

FDA Releases CDRH Health of Women Strategic Plan to Better Inform ...

January 18, 2022 — The following statement was issued today by the U.S. Food and Drug Administration (FDA), and is ...

Time January 18, 2022
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The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) jointly issued the Good Machine Learning Practice for Medical Device Development: Guiding Principles.
News | Information Technology

Good Machine Learning Practice for Medical Device Development: Guiding ...

October 27, 2021 — The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s (UK) Medicines ...

Time October 27, 2021
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Paige Prostate, is the first artificial intelligence (AI)-based software designed to identify an area of interest on the prostate biopsy image with the highest likelihood of harboring cancer so it can be reviewed further by the pathologist if the area of concern has not been identified on initial review.
News | Digital Pathology

FDA Authorizes Software That Can Help Identify Prostate Cancer

September 22, 2021 — The U.S. Food and Drug Administration authorized marketing of software to assist medical ...

Time September 22, 2021
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#breakingnews The U.S. Food and Drug Administration (FDA) just granted full approval to the Pfizer/BioNTech Covid-19 vaccine for people age 16 and older. It is the first vaccine to be fully approved by the FDA, and experts say it is expected to open the door for further vaccine mandates.
News | Coronavirus (COVID-19)

Pfizer-BioNTech COVID-19 Vaccine Gets Full Approval from FDA

August 23, 2021 — The U.S. Food and Drug Administration (FDA) just granted full approval to the Pfizer/BioNTech COVID-19 ...

Time August 23, 2021
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In the #medical device ecosystem, #collaborative_communities bring together stakeholders to achieve common outcomes, solve shared challenges, and leverage collective opportunities #FDA
News | Radiology Imaging

FDA Participates in New ‘Collaborative Communities’ to Address ...

August 4, 2021 — The U.S. Food and Drug Administration announced participation in several new collaborative communities  ...

Time August 04, 2021
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Aduhelm should be initiated in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia
News | PET Imaging

FDA Approves Updated Aduhelm Prescribing Information

July 8, 2021 — Biogen and Eisai Co., Ltd. announced the U.S. Food and Drug Administration (FDA) has approved an updated ...

Time July 08, 2021
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