Bridging Regulatory & Reimbursement

Everybody is looking for Evidence — Bridging Regulatory & Reimbursement: Strategies for Success

By Christy Sheehy, PhD, Jenny Levinson

…plan ahead for market access. Our industry develops innovative products to improve human health, and reimbursement gives patients access to these life-changing medical technologies.   1 https://medtechintelligence.com/news_article/fda-issues-updated-draft-guidance-on-use-of-real-world-evidence/ 2 https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices#resources 3…

…plan ahead for market access. Our industry develops innovative products to improve human health, and reimbursement gives patients access to these life-changing medical technologies.   1 https://medtechintelligence.com/news_article/fda-issues-updated-draft-guidance-on-use-of-real-world-evidence/ 2 https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices#resources 3…

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Regulatory Survey 2024

SURVEY: Managing global regulatory strategy and compliance – assessing status, gaps, and needs.

By Celegence, MedTech Intelligence Staff

celMore resources, expertise, and technology, please! The common theme illustrated in a recent survey among medical device regulatory professionals is the need for increased resources, expertise, and technology. The data…

celMore resources, expertise, and technology, please! The common theme illustrated in a recent survey among medical device regulatory professionals is the need for increased resources, expertise, and technology. The data…

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FDA

FDA publishes long-awaited clinical trial diversity guidance

By Hogan Lovells Engage

From our publishing partner:   The U.S. Food and Drug Administration (FDA) has issued its long-awaited draft guidance, “Diversity Action Plans to Enrollment of Participants from Underrepresented Populations in Clinical…

From our publishing partner:   The U.S. Food and Drug Administration (FDA) has issued its long-awaited draft guidance, “Diversity Action Plans to Enrollment of Participants from Underrepresented Populations in Clinical…

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LDT-laboratory Developed Test

FDA under fire: Pared-down LDT Final Rule leaves unanswered questions

By Hogan Lovells Engage

The U.S. Food and Drug Administration (FDA) has finalized its historic — and notoriously controversial — rule to explicitly assert the agency’s authority to regulate laboratory developed tests (LDTs). Below…

The U.S. Food and Drug Administration (FDA) has finalized its historic — and notoriously controversial — rule to explicitly assert the agency’s authority to regulate laboratory developed tests (LDTs). Below…

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Combination Devices: new guidance for industry and notified bodies

Revision of Guidance: A new revision of the guidance available to applicants, marketing authorisation holders and notified bodies of medical devices has been published today. This question-and-answer document provides practical…

Revision of Guidance: A new revision of the guidance available to applicants, marketing authorisation holders and notified bodies of medical devices has been published today. This question-and-answer document provides practical…

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Healthcare Technology

The Role of EPSS in Prioritizing IoMT Security Threats

By Shankar Somasundaram

…the most.   References: [i] “Unpatched and Outdated Medical Devices Provide Cyber Attack Opportunities,” Federal Bureau of Investigation, September 12, 2022, https://www.ic3.gov/Media/News/2022/220912.pdf [ii] “The EPSS Model,” FIRST, https://www.first.org/epss/model [iii] “Exploit…

…the most.   References: [i] “Unpatched and Outdated Medical Devices Provide Cyber Attack Opportunities,” Federal Bureau of Investigation, September 12, 2022, https://www.ic3.gov/Media/News/2022/220912.pdf [ii] “The EPSS Model,” FIRST, https://www.first.org/epss/model [iii] “Exploit…

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Errol Weiss

Information Sharing: A Valuable Tool in Preventing Cyber Attacks

By MedTech Intelligence Staff

…as much because it’s not creating headline news. To answer the question, ransomware is all about money. They don’t care who they’re attacking. They are opportunistic. They launch attack and…

…as much because it’s not creating headline news. To answer the question, ransomware is all about money. They don’t care who they’re attacking. They are opportunistic. They launch attack and…

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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

Pure Global, a provider of global market access services, and MEDIcept, a consultancy offering U.S. and EU regulatory, quality, and clinical services, are joining forces to support regulatory compliance and…

Pure Global, a provider of global market access services, and MEDIcept, a consultancy offering U.S. and EU regulatory, quality, and clinical services, are joining forces to support regulatory compliance and…

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FDA Logo

FDA Releases Laboratory Developed Tests Final Rule

By MedTech Intelligence Staff

…as LDTs, news articles and class-action lawsuits. Concerns with Unsafe, Inaccurate Tests The FDA cited the growing risk of potentially inaccurate, unsafe, ineffective or poor quality IVDs offered as LDTs…

…as LDTs, news articles and class-action lawsuits. Concerns with Unsafe, Inaccurate Tests The FDA cited the growing risk of potentially inaccurate, unsafe, ineffective or poor quality IVDs offered as LDTs…

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