Clinical Evaluation

Role of Clinical Evaluation Report Consultants

By Anushree Singh

…seamless journey through the clinical evaluation process. Using CER Consultants and Advance Compliance Software Consultants can be a wealth of knowledge to help you navigate through the complex regulatory challenges…

…seamless journey through the clinical evaluation process. Using CER Consultants and Advance Compliance Software Consultants can be a wealth of knowledge to help you navigate through the complex regulatory challenges…

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European Union Flag

European Commission Proposes Extension for EU IVDR Compliance

By MedTech Intelligence Staff

On January 23, the European Commission put forth a proposal that would extend the deadline for compliance with EU In Vitro Diagnostic Medical Devices Regulation (IVDR), under certain conditions. The…

On January 23, the European Commission put forth a proposal that would extend the deadline for compliance with EU In Vitro Diagnostic Medical Devices Regulation (IVDR), under certain conditions. The…

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FDA Logo

FDA To Host Town Hall on Medical Device Sterilization

By MedTech Intelligence Staff

The FDA will host the second in a series of medical device sterilization town halls on Friday, January 26, 2024 from 12:00pm-1:00 pm ET. This session, “FDA Activities and Challenges…

The FDA will host the second in a series of medical device sterilization town halls on Friday, January 26, 2024 from 12:00pm-1:00 pm ET. This session, “FDA Activities and Challenges…

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Neeraj Mainkar

Advancements in AI: Shaping the Future of Spine Surgery

By Neeraj Mainkar

…to a variety of data concerns and a complex regulatory framework. Robotic vision is another area of AI application in surgery, although it is more developed in abdominal surgeries than…

…to a variety of data concerns and a complex regulatory framework. Robotic vision is another area of AI application in surgery, although it is more developed in abdominal surgeries than…

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Red Blood Cells Illustration

FDA Approves Second Indication for Casgevy Cell-based Gene Therapy

By MedTech Intelligence Staff

…Products within the FDA’s Center for Biologics Evaluation and Research. “The approval of a cell-based gene therapy for this condition using CRISPR/Cas9 technology reflects FDA’s continued commitment to supporting safe…

…Products within the FDA’s Center for Biologics Evaluation and Research. “The approval of a cell-based gene therapy for this condition using CRISPR/Cas9 technology reflects FDA’s continued commitment to supporting safe…

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MaryAnne Rizk

MaryAnne Rizk Joins Blue Spark Technologies Board of Advisors

By MedTech Intelligence Staff

Blue Spark Technologies, a digital health company specializing in AI-powered remote patient monitoring (RPM) to support precision drug development, has appointed MaryAnne Rizk, Ph.D., a leader in drug development technological…

Blue Spark Technologies, a digital health company specializing in AI-powered remote patient monitoring (RPM) to support precision drug development, has appointed MaryAnne Rizk, Ph.D., a leader in drug development technological…

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PreciseDX

How AI Can Advance Breast Cancer Detection and Treatment

By Ted M. Diehl, Wayne Brinster

…disease. This more precise and personalized approach holds the promise of better patient outcomes and new levels of health care efficiency and effectiveness. References: [1]https://www.bcrf.org/breast-cancer-statistics-and-resources/#:~:text=Breast%20cancer%20is%20the%20most%20common%20cancer%20in%20women%20overall,140%20of%20184%20countries%20worldwide. [2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10328041/ [3]https://www.aha.org/aha-center-health-innovation-market-scan/2023-05-09-how-ai-improving-diagnostics-decision-making-and-care#:~:text=AI%20algorithms%20analyze%20a%20vast,patient%20over%20the%20next%20several. [4]https://www.sciencedirect.com/science/article/abs/pii/S1568494621008085#:~:text=For%20a%20favorable%20prognosis%20of,stained%20with%20Hematoxylin%20and%20Eosin [5]https://www.basscancercenter.com/cancer-blog/breast-cancer-follow-up-care-guidelines#:~:text=After%20completing%20your%20breast%20cancer,emotional%20and%20physical%20well%2Dbeing….

…disease. This more precise and personalized approach holds the promise of better patient outcomes and new levels of health care efficiency and effectiveness. References: [1]https://www.bcrf.org/breast-cancer-statistics-and-resources/#:~:text=Breast%20cancer%20is%20the%20most%20common%20cancer%20in%20women%20overall,140%20of%20184%20countries%20worldwide. [2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10328041/ [3]https://www.aha.org/aha-center-health-innovation-market-scan/2023-05-09-how-ai-improving-diagnostics-decision-making-and-care#:~:text=AI%20algorithms%20analyze%20a%20vast,patient%20over%20the%20next%20several. [4]https://www.sciencedirect.com/science/article/abs/pii/S1568494621008085#:~:text=For%20a%20favorable%20prognosis%20of,stained%20with%20Hematoxylin%20and%20Eosin [5]https://www.basscancercenter.com/cancer-blog/breast-cancer-follow-up-care-guidelines#:~:text=After%20completing%20your%20breast%20cancer,emotional%20and%20physical%20well%2Dbeing….

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