From our publishing partner: The U.S. Food and Drug Administration (FDA) has issued its long-awaited draft guidance, “Diversity Action Plans to Enrollment of Participants from Underrepresented Populations in Clinical…
From our publishing partner: The U.S. Food and Drug Administration (FDA) has issued its long-awaited draft guidance, “Diversity Action Plans to Enrollment of Participants from Underrepresented Populations in Clinical…
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…
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…
…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 References: [i] “Unpatched and Outdated Medical Devices Provide Cyber Attack Opportunities,” Federal Bureau of Investigation, September 12, 2022, https://www.ic3.gov/Media/News/2022/220912.pdf [ii]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 References: [i] “Unpatched and Outdated Medical Devices Provide Cyber Attack Opportunities,” Federal Bureau of Investigation, September 12, 2022, https://www.ic3.gov/Media/News/2022/220912.pdf [ii]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…
…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…
…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…
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…
…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…
…Diversity: Gather information from various sources such as industry reports, specialized and mainstream news outlets, and academic research to ensure a more balanced view. Expertise: Build a network of founders,…
…Diversity: Gather information from various sources such as industry reports, specialized and mainstream news outlets, and academic research to ensure a more balanced view. Expertise: Build a network of founders,…
…still no time for organizations to let down their guard against the risks. The good news, of course, is the sharp reduction in the rate of inflation, which gives many…
…still no time for organizations to let down their guard against the risks. The good news, of course, is the sharp reduction in the rate of inflation, which gives many…
