Errol Weiss

Information Sharing: A Valuable Tool in Preventing Cyber Attacks

By MedTech Intelligence Staff

…spoke with Errol Weiss, Chief Security Officer of the Health-ISAC. Here, we discuss the history of ISACs, tools available to support member companies and emerging threats. What is an ISAC?…

…spoke with Errol Weiss, Chief Security Officer of the Health-ISAC. Here, we discuss the history of ISACs, tools available to support member companies and emerging threats. What is an ISAC?…

Continue reading

FDA Logo

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…

Continue reading

FDA Logo

FDA Launches Health Care at Home Initiative

By MedTech Intelligence Staff

…scale. The hub will be designed as an Augmented Reality/Virtual Reality (AR/VR)-enabled home prototype and is expected to be completed later this year. CDRH is also collaborating with patient groups,…

…scale. The hub will be designed as an Augmented Reality/Virtual Reality (AR/VR)-enabled home prototype and is expected to be completed later this year. CDRH is also collaborating with patient groups,…

Continue reading

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…

Continue reading

Collaboration Puzzle Piece Graphic

Pure Global and MEDIcept Join Forces to Expand Market Access Services

By MedTech Intelligence Staff

…to bolster capacity and expertise Designing pre- and post-market global clinical studies for comprehensive support Empowering research efficiency through Pure Global’s AIGC tools “Pure Global’s strategic alliance with MEDIcept will…

…to bolster capacity and expertise Designing pre- and post-market global clinical studies for comprehensive support Empowering research efficiency through Pure Global’s AIGC tools “Pure Global’s strategic alliance with MEDIcept will…

Continue reading

FDA Logo

FDA Releases Laboratory Developed Tests Final Rule

By MedTech Intelligence Staff

…to the final rule, where that program’s review of analytical and clinical validity helps to mitigate the risk of harm from inaccurate and unreliable LDTs. To helps companies comply with…

…to the final rule, where that program’s review of analytical and clinical validity helps to mitigate the risk of harm from inaccurate and unreliable LDTs. To helps companies comply with…

Continue reading

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…

Continue reading

Artificial Intelligence Graphic

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…

Continue reading