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‘22 in review

FDA finalizes CDS guidance, but AI guidance for change control a low priority

Dec. 29, 2022
By Mark McCarty
The U.S. FDA managed to wrap up a guidance for clinical decision support (CDS) products after several years, one of several projects the agency was liable for in the area of digital health. While a much-needed draft guidance for change control for artificial intelligence algorithms made the guidance agenda for the FDA’s new fiscal year, that draft is only a B draft guidance priority, suggesting that a final guidance might not emerge until calendar year 2024, possibly later.
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ECTRIMS 2022

Biogen data demonstrates potential of digital health to support MS care

Oct. 28, 2022
By Meg Bryant
Biogen Inc. presented new data showing how applying artificial intelligence (AI), machine learning (ML) and radiomics can produce actionable insights on multiple sclerosis (MS) disease progression. The results, released at this week’s European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress, could help to advance new digital health tools to improve monitoring and quality of life of MS patients.
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Drug Design, Drug Delivery & Technologies

AI model helps make preclinical drug design more accurate

Oct. 20, 2022
By Helen Albert
Researchers based at the City University of New York (CUNY) have designed a deep learning artificial intelligence (AI) model that can improve preclinical predictions of drug responses in humans. As outlined in the Oct. 17, 2022, online issue of Nature Machine Intelligence, the researchers believe their model – a context-aware deconfounding autoencoder (CODE-AE) – can help improve the quality of early drug response prediction and help reduce subsequent clinical trial failures.
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Artificial intelligence and digital health icons
Drug Design, Drug Delivery & Technologies

AI model helps make preclinical drug design more accurate

Oct. 19, 2022
By Helen Albert
Researchers based at the City University of New York (CUNY) have designed a deep learning artificial intelligence (AI) model that can improve preclinical predictions of drug responses in humans. As outlined in the Oct. 17, 2022, online issue of Nature Machine Intelligence, the researchers believe their model – a context-aware deconfounding autoencoder (CODE-AE) – can help improve the quality of early drug response prediction and help reduce subsequent clinical trial failures.
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Brain anomalies identified by the MELD AI algorithm

AI detects anomalies responsible for epilepsy seizures

Sep. 1, 2022
By Bernard Banga
International research project Multicentre Epilepsy Lesion Detection (MELD), led by University College London, has developed artificial intelligence software that can identify minute brain anomalies that lead to epilepsy seizures. These anomalies, known as focal cortical dysplasia, can often be treated with surgery but are difficult to visualize on an MRI.
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Federal Circuit short-circuits attempt to provide inventorship for AI

Aug. 12, 2022
By Mark McCarty
The question of whether an artificial intelligence (AI) algorithm should enjoy the status of an inventor has been making the rounds in various nations, but the U.S. Court of Appeals for the Federal Circuit has rejected the notion based on a plain reading of the statute. The court said that the statute is unambiguous in that only natural persons can claim inventorship, but the question will be appealed to the Supreme Court, which will have an opportunity to put this debate to rest.
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Chinese yuan and piggy bank

Fosun Aitrox raises $14M in a strategic financing

Aug. 12, 2022
By Zhang Mengying
Shanghai Aitrox Technology Co. Ltd. (Fosun Aitrox) completed strategic financing of over ¥100 million (US$14.8 million) to develop its pipelines in artificial intelligence (AI)-aided diagnosis platforms. This financing was led by Shanghai Fosun Pharmaceutical (Group) Co. Ltd. and Sinopharm-CICC (Shanghai) Private Equity Investment Management Co. Ltd.
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Man undergoing MRI scan for prostate cancer diagnosis

FDA advances AI-enhanced tech for prostate diagnosis and treatment

Aug. 9, 2022
By Annette Boyle
Recent U.S. FDA actions could transform decades of prostate cancer care. Two companies focused on prostate cancer received good news from the FDA for their artificial intelligence (AI)-driven software. Bot Image Inc. gained FDA clearance for its medical device computer-aided detection and diagnostic tool, Prostatid. The agency also provided FDA investigational device exemption for Avenda Health Inc.’s Focalpoint ablation system that enables more accurate mapping of a patient’s prostate cancer for better surgical results.
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