FDA's ISTAND Pilot Program accepts submission of first artificial intelligence based and digital health technology for neuroscience

23 January 2024 - FDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research recently accepted a ...

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Where medical statistics meets artificial intelligence

28 September 2023 - Challenges at the interface of medical statistics and AI are population inference versus prediction, generalisability, reproducibility and ...

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Health care regulators’ outdated thinking will cost American ives

10 April 2023 - In a matter of months, ChatGPT has radically altered our nation’s views on artificial intelligence—uprooting old ...

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FDA draft guidance allows AI/ML devices to evolve without requiring new submissions

31 March 2023 - The US FDA published a draft guidance outlining how sponsors of artificial intelligence and machine learning (AI/ML) ...

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AI developers battle with FDA, what’s next with Amazon and One Medical, & protecting wearables data

23 February 2023 - Health tech companies are in a tizzy. After years of letting companies roll out software tools to ...

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The future of voice technologies in health care

13 February 2023 - Adam Smith believed that the division of labor is the key to growth.  ...

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Four types of bias in medical AI are running under the FDA’s radar

9 January 2023 - Although artificial intelligence is entering health care with great promise, clinical artificial intelligence tools are prone ...

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In new guidance, FDA says AI tools to warn of sepsis should be regulated as devices

27 September 2022 - The FDA on Tuesday published a list of artificial intelligence tools that should be regulated as ...

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FDA grants breakthrough device designation for CurveBeam AI's OssView bone fragility software

12 September 2022 - CurveBeam announced its medical diagnostic software, OssView, has received US FDA breakthrough device designation.  ...

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Amazon versus Apple: only one will rewrite the rules of health care

29 August 2022 - Big tech has had a surprisingly small impact on U.S. healthcare, so far. ...

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Artificial intelligence was supposed to transform health care. It hasn’t.

15 August 2022 - Machine learning could improve medicine by analysing data to improve diagnoses and target cures, but technological, bureaucratic, ...

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Bot Image receives FDA clearance for artificial intelligence software used in detection and diagnosis of prostate cancer

8 August 2022 - Bot Image has developed an AI driven medical device CAD software to significantly improve the accuracy and ...

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FDA should step in to help spur AI/ML standards

13 June 2022 - The US FDA should support the burgeoning integration of artificial intelligence and machine learning in medical ...

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FDA grants breakthrough device designation to Anumana’s ECG pulmonary hypertension early detection AI algorithm

24 May 2022 - Anumana today announced that the U.S. FDA has granted breakthrough device designation to its AI-enhanced, ECG based ...

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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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