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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510k Submission Planning

510k Submission Planning

By Joy Greidanus

…– FDA FDA 510(k) Submission Process FDA 510(k) database   Tip #3: Create A Substantial Equivalence Comparison Table Document your findings in a table which compares the potential predicates to…

…– FDA FDA 510(k) Submission Process FDA 510(k) database   Tip #3: Create A Substantial Equivalence Comparison Table Document your findings in a table which compares the potential predicates to…

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FDA Logo

FDA Announces Cardiac Health and AI Model Predictions (V-CHAMPS) Challenge Winners

By MedTech Intelligence Staff

…judged by a combination of clinical and data science subject matter experts, and were evaluated on several aspects, including: Innovation in clinical predictors Completeness of data science approach Statistical metrics…

…judged by a combination of clinical and data science subject matter experts, and were evaluated on several aspects, including: Innovation in clinical predictors Completeness of data science approach Statistical metrics…

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Medtronic Percept RC

FDA Approves Medtronic Percept RC Neurostimulator for Deep Brain Stimulation

By MedTech Intelligence Staff

The FDA has approved Medtronic’s Percept RC Deep Brain Stimulation (DBS) system for patients with movement disorders such as Parkinson’s disease, essential tremor, dystonia and epilepsy. The surgically implanted Medtronic…

The FDA has approved Medtronic’s Percept RC Deep Brain Stimulation (DBS) system for patients with movement disorders such as Parkinson’s disease, essential tremor, dystonia and epilepsy. The surgically implanted Medtronic…

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Sudhir Kesavan

CitiusTech Appoints Sudhir Kesavan as Chief Operating Officer

By MedTech Intelligence Staff

…of Bangalore, India, Kesavan joins CitiusTech from PwC India, where he served as Partner, Advisory – Cloud Transformation. Previously, he worked for large-scale IT companies including Wipro and Tata Consultancy…

…of Bangalore, India, Kesavan joins CitiusTech from PwC India, where he served as Partner, Advisory – Cloud Transformation. Previously, he worked for large-scale IT companies including Wipro and Tata Consultancy…

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