Medical devices take multiple years and millions of dollars to bring to market. Regulations play a huge role: medtech manufacturers must meet a range of requirements to get devices approved – or risk wasting…
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During the House Energy and Commerce Health Subcommittee hearing on the U.S. Food and Drug Administration’s regulation of drugs, biologics and medical devices on Wednesday, representatives fired questions at FDA directors. The lawmakers said they…
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Digital mental health technologies (DMHT) should be used as part of a wider treatment package alongside regular therapy sessions and/or prescribed medication, according to patients who took part in research commissioned by the Medicines…
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Language models (LMs) such as BERT and GPT have revolutionized natural language processing (NLP). However, the medical field faces challenges in training LMs due to limited data access and privacy constraints imposed by regulations…
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The following is a guest article by Nitin Kunte, Sr. Director at NTT DATA
On February 8, 2024, the Office of the National Coordinator for Health Information Technology (ONC) published the Health Data, Technology, and…
Health technology assessment (HTA) is a formidable task across drug development, medical device innovation, and digital health solutions. To help with this task, the European HTA Regulation entered into force in January 2022 and will apply…
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3D printing has emerged as a transformative technology in healthcare in recent years. The number of U.S. hospitals with centralized 3D printing facilities for point-of-care manufacturing has exploded, from just three in 2010 to…
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Digital health innovation is expected to transform healthcare, but it also generates ethical and societal concerns, such as privacy risks, and biases that can compound existing health inequalities. While such concerns are widely recognized,…
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Philips received a warning letter from the FDA in February, which the Agency posted on Tuesday, stating that an inspection of the tech giant’s manufacturing facility in Suzhou, China that makes CT and ultrasonography…
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Philips received a warning letter from the FDA in February, which the Agency posted on Tuesday, stating that an inspection of the tech giant’s manufacturing facility in Suzhou, China, that makes CT and ultrasonography…
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