Dental AI start-up wins second FDA clearance to detect top oral diseases

16 May 2022 - The FDA has awarded dental AI start-up Overjet with landmark clearance to use its software to ...

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FDA authorises marketing of virtual reality system for chronic pain reduction

16 November 2021 - The U.S. FDA today authorized marketing of EaseVRx, a prescription-use immersive virtual reality system that uses cognitive ...

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FDA collaborates with Health Canada and UK’s MHRA to foster good machine learning practice

27 October 2021 - Today, the U.S. FDA, Health Canada and the United Kingdom’s MHRA jointly issued the “Good Machine Learning ...

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The FDA should better regulate medical algorithms

7 October 2021 - Most do not require the agency’s approval, and those that do often don’t require clinical trials. ...

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Artificial intelligence in medicine regulation

16 August 2021 - The International Coalition of Medicines Regulatory Authorities sets out recommendations to help regulators to address the ...

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Abbott receives FDA clearance for its imaging technology using artificial intelligence for vessels in the heart

3 August 2021 - Ultreon 1.0 software, the first-of-its-kind imaging software, merges optical coherence tomography with the power of automation using ...

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Sensome receives FDA breakthrough device designation for its AI powered stroke guidewire

21 June 2021 - Sensome announced today that it has been granted a Breakthrough Device designation by the Center of Devices ...

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Viome receives FDA approval for its unique mRNA technology and AI platform to detect cancers

6 May 2021 - FDA breakthrough designation validates Viome's proprietary mRNA analysing technology and state of the art AI platform to ...

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FDA authorises marketing of first device that uses artificial intelligence to help detect potential signs of colon cancer

9 April 2021 - Medical device aids clinicians in detecting potential irregularities during colon cancer screening and surveillance. ...

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Optellum receives FDA clearance for the world’s first AI-powered clinical decision support software for early lung cancer diagnosis

23 March 2021 - Virtual Nodule Clinic empowers clinicians to make optimal clinical decisions in early-stage lung cancer diagnosis and is ...

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FDA authorises first machine learning-based screening device to identify certain biomarkers that may indicate COVID-19 infection

19 March 2021 - Device may be used to identify biomarkers indicative of SARS-CoV-2 infection among certain asymptomatic individuals following a ...

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FDA releases artificial intelligence/machine learning action plan

12 January 2021 - Today, the U.S. FDA released the agency’s first artificial intelligence/machine learning-based software as a Medical Device Action ...

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Deep dive into big pharma AI productivity: one study shaking the pharmaceutical industry

15 July 2020 - The pharmaceutical business is perhaps the only industry on the planet, where to get the product from ...

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Randomised clinical trials of artificial intelligence

17 February 2020 - As patient data are increasingly captured digitally, the opportunities to deploy artificial intelligence, especially machine learning, ...

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Challenges to the reproducibility of machine learning models in health care

6 January 2020 - Reproducibility has been an important and intensely debated topic in science and medicine for the past few ...

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