Errol Weiss

Information Sharing: A Valuable Tool in Preventing Cyber Attacks

By MedTech Intelligence Staff

…billion dollar business—so they have plenty of money to spend on new capabilities. Two years later, that is still true, but with generative AI they’ve got free access to some…

…billion dollar business—so they have plenty of money to spend on new capabilities. Two years later, that is still true, but with generative AI they’ve got free access to some…

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FDA Issues Final Guidance on Remanufacturing of Medical Devices

By MedTech Intelligence Staff

…the anatomical location of use) and offers a flow chart for activities involving components/parts/materials to help entities determine if their activities are likely remanufacturing. The FDA notes that while the…

…the anatomical location of use) and offers a flow chart for activities involving components/parts/materials to help entities determine if their activities are likely remanufacturing. The FDA notes that while the…

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FDA Launches Health Care at Home Initiative

By MedTech Intelligence Staff

…the past decade, which is disproportionately borne by underserved communities and communities of color.. The FDA noted that by shifting the U.S. healthcare model from systems to people, the healthcare…

…the past decade, which is disproportionately borne by underserved communities and communities of color.. The FDA noted that by shifting the U.S. healthcare model from systems to people, the healthcare…

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Penny Pinnock

Unleashing AI Potential in Medical Imaging

By Penny Pinnock

…constrained budgets, and where relevant, support national healthcare systems with ever-growing patient demand. References: [1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10680162/ [2] https://www.theguardian.com/society/2023/aug/02/ai-use-breast-cancer-screening-study-preliminary-results [3] https://news.harvard.edu/gazette/story/2023/03/using-ai-to-target-alzheimers/ [4] https://www.rcr.ac.uk/news-policy/policy-reports-initiatives/clinical-radiology-census-reports/ [5] https://www.hcinnovationgroup.com/imaging/blog/53079004/on-the-way-to-rsna23-what-about-that-radiologist-shortage [6] https://www.gov.uk/government/news/21-million-to-roll-out-artificial-intelligence-across-the-nhs ; https://www.healthcarefinancenews.com/news/ai-changing-healthcare-operations-and-where-investment-going [7] www.siemens.com/financing-digital-transformation-healthcare…

…constrained budgets, and where relevant, support national healthcare systems with ever-growing patient demand. References: [1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10680162/ [2] https://www.theguardian.com/society/2023/aug/02/ai-use-breast-cancer-screening-study-preliminary-results [3] https://news.harvard.edu/gazette/story/2023/03/using-ai-to-target-alzheimers/ [4] https://www.rcr.ac.uk/news-policy/policy-reports-initiatives/clinical-radiology-census-reports/ [5] https://www.hcinnovationgroup.com/imaging/blog/53079004/on-the-way-to-rsna23-what-about-that-radiologist-shortage [6] https://www.gov.uk/government/news/21-million-to-roll-out-artificial-intelligence-across-the-nhs ; https://www.healthcarefinancenews.com/news/ai-changing-healthcare-operations-and-where-investment-going [7] www.siemens.com/financing-digital-transformation-healthcare…

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Collaboration Puzzle Piece Graphic

Pure Global and MEDIcept Join Forces to Expand Market Access Services

By MedTech Intelligence Staff

…help accelerate MedTech innovation and streamline compliance. By combining their hundreds of successful submissions since 1996 with our AI-powered and data driven regulatory solutions, we empower clients worldwide to bring…

…help accelerate MedTech innovation and streamline compliance. By combining their hundreds of successful submissions since 1996 with our AI-powered and data driven regulatory solutions, we empower clients worldwide to bring…

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FDA Releases Laboratory Developed Tests Final Rule

By MedTech Intelligence Staff

…to rely on results of these tests without assurance that they work,” said FDA Commissioner Robert M. Califf, M.D. “The final rule announced today aims to provide crucial oversight of…

…to rely on results of these tests without assurance that they work,” said FDA Commissioner Robert M. Califf, M.D. “The final rule announced today aims to provide crucial oversight of…

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Nicholas Lesniewski-Laas

Misconceptions of Miniaturization (Part 3): Smaller is Cheaper

By Nicholas Lesniewski-Laas

…as I know no studies have explicitly demonstrated that people ascribe higher monetary value to larger or heavier objects directly. https://www.ncbi.nlm.nih.gov/pubmed/19686292 [2] https://www.ncbi.nlm.nih.gov/pubmed/10598479 https://qz.com/18246/apple-google-and-amazon-are-so-profitable-because-they-know-what-to-lose-money-on/ [3] https://www.cbsnews.com/video/the-anatomy-of-an-iphone-camera/ [4] https://technology.ihs.com/451424/apple-continues-familiar-design-and-pricing-strategy-with-iphone-5c-ihs-teardown-reveals [5] https://technology.ihs.com/410378/iphone-5-carries-199-bom-virtual-teardown-reveals…

…as I know no studies have explicitly demonstrated that people ascribe higher monetary value to larger or heavier objects directly. https://www.ncbi.nlm.nih.gov/pubmed/19686292 [2] https://www.ncbi.nlm.nih.gov/pubmed/10598479 https://qz.com/18246/apple-google-and-amazon-are-so-profitable-because-they-know-what-to-lose-money-on/ [3] https://www.cbsnews.com/video/the-anatomy-of-an-iphone-camera/ [4] https://technology.ihs.com/451424/apple-continues-familiar-design-and-pricing-strategy-with-iphone-5c-ihs-teardown-reveals [5] https://technology.ihs.com/410378/iphone-5-carries-199-bom-virtual-teardown-reveals…

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Demystifying Regulatory Hurdles: How to Navigate FDA Approval for AI-Enabled Medical Devices

By Cory Hayes, Jeanna Blitz

…1/16/2024, https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices US Food and Drug Administration (FDA). Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD). Accessed 12/21/2023, https://www.fda.gov/media/122535/download?attachment US Food and…

…1/16/2024, https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices US Food and Drug Administration (FDA). Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD). Accessed 12/21/2023, https://www.fda.gov/media/122535/download?attachment US Food and…

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