HeartFlow Logo

HeartFlow AI Plaque Analysis Shows 95% Accuracy vs. Invasive Imaging

By MedTech Intelligence Staff

The multicenter international study, which enrolled 258 patients across 15 sites in the U.S. and Japan, compared HeartFlow’s automated deep-learning-based method for segmenting coronary atherosclerosis in coronary computed tomography angiography…

The multicenter international study, which enrolled 258 patients across 15 sites in the U.S. and Japan, compared HeartFlow’s automated deep-learning-based method for segmenting coronary atherosclerosis in coronary computed tomography angiography…

Continue reading

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…

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

…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…

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