Regulatory approaches to stimulate innovative renal replacement therapies von Wieringa, Fokko P., Sheldon, Murray I., Hidalgo-Simon, Ana

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The Kidney Health Initiative innovation roadmap for renal replacement therapies: Building the yellow brick road, while updating the map von Wieringa, Fokko P., Sheldon, Murray

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Early technology review: towards an expedited pathway von Levin, Leslie, Sheldon, Murray, McDonough, Robert S., Aronson, Naomi, Rovers, Maroeska, Gibson, C. Michael, Tunis, Sean Robert, Kuntz, Richard E.

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Overview of Various Components of the Science of Patient Input: Advancing the Use of Patient-Reported, Real-World Evidence for Medical Device Evaluation of Innovative Products for... von Sheldon, Murray

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Generating evidence for new high-risk medical devices von Campbell, Bruce, Wilkinson, John, Marlow, Mirella, Sheldon, Murray

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Moving ahead on the Kidney Health Initiative innovation roadmap, a transatlantic progress update von Wieringa, Fokko P., Sheldon, Murray, Ash, Stephen R., Groth, Thomas, Boomker, Jasper, Oostrom, Tom, Vanholder, Raymond

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Developing the foundation for assessment of Devices used for Acute Ischemic Stroke Interventions (DAISI) using a Coordinated Registry Network von LeRoy, Hartley, Gressler, Laura Elisabeth, Liebeskind, David S, Brooks, Claudette E, Siddiqui, Adnan, Ansari, Sameer A, Sheldon, Murray, Pena, Carlos, Sedrakyan, Art, Marinac-Dabic, Danica

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Parkinson’s Patients’ Tolerance for Risk and Willingness to Wait for Potential Benefits of Novel Neurostimulation Devices: A Patient-Centered Threshold Technique Study von Hauber, Brett, Mange, Brennan, Zhou, Mo, Chaudhuri, Shomesh, Benz, Heather L., Caldwell, Brittany, Ruiz, John P., Saha, Anindita, Ho, Martin, Christopher, Stephanie, Bardot, Dawn, Sheehan, Margaret, Donnelly, Anne, McLaughlin, Lauren, Gwinn, Katrina, Lo, Andrew, Sheldon, Murray

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Advancing the Real-World Evidence for Medical Devices through Coordinated Registry Networks von Sedrakyan, Art, Marinac-Dabic, Danica, Campbell, Bruce, Aryal, Suvekshya, Baird, Courtney E, Goodney, Philip, Cronenwett, Jack L, Beck, Adam W, Paxton, Elizabeth W, Hu, Jim, Brindis, Ralph, Baskin, Kevin, Cowley, Terrie, Levy, Jeffery, Liebeskind, David S, Poulose, Benjamin K, Rardin, Charles R, Resnic, Frederic S, Tcheng, James, Fisher, Benjamin, Viviano, Charles, Devlin, Vincent, Sheldon, Murray, Eldrup-Jorgensen, Jens, Berlin, Jesse A, Drozda, Joseph, Matheny, Michael E, Dhruva, Sanket S, Feeney, Timothy, Mitchell, Kristi, Pappas, Gregory

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Working With the Food and Drug Administration's Center for Devices to Advance Regulatory Science and Medical Device Innovation von Malinauskas, Richard A., Saha, Anindita, Sheldon, Murray I.

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Patient-Centered Identification of Meaningful Regulatory Endpoints for Medical Devices to Treat Parkinson’s Disease von Benz, Heather L., Caldwell, Brittany, Ruiz, John P., Saha, Anindita, Ho, Martin, Christopher, Stephanie, Bardot, Dawn, Sheehan, Margaret, Donnelly, Anne, McLaughlin, Lauren, Mange, Brennan, Hauber, A. Brett, Gwinn, Katrina, Heetderks, William J., Sheldon, Murray

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Long-term evidence for new high-risk medical devices von Campbell, Bruce, Wilkinson, John, Marlow, Mirella, Sheldon, Murray

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A Technology Roadmap for Innovative Approaches to Kidney Replacement Therapies: A Catalyst for Change von Bonventre, Joseph V, Hurst, Frank P, West, Melissa, Wu, Iwen, Roy-Chaudhury, Prabir, Sheldon, Murray

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Risk Tolerance in the Setting of Wearable Dialysis Devices: A Patient Preference Study Using the Threshold Technique von Flythe, Jennifer E, Forfang, Derek, Harris, Raymond C, Wood, Dallas, Hurst, Frank P, Tarver, Michelle E

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Long-term evidence for new high-risk medical devices von Campbell, Bruce, Wilkinson, John, Marlow, Mirella, Murray, Sheldon

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Patient-centered clinical trials von Chaudhuri, Shomesh E., Ho, Martin P., Irony, Telba, Sheldon, Murray, Lo, Andrew W.

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Patient-Centered Clinical Trial Design: A Case Study in Parkinson’s Disease (P2.8-008) von Gwinn, Katrina, Chaudhuri, Shomesh, Hauber, A., Mange, Brennan, Benz, Heather, Caldwell, Brittany, Saha, Anindita, Ho, Martin, Christopher, Stephanie, Sheehan, Margaret, Donnelly, Anne, McLaughlin, Lauren, Sheldon, Murray, Lo, Andrew

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Use of Bayesian decision analysis to maximize value in patient-centered randomized clinical trials in Parkinson's disease von Chaudhuri, Shomesh E., Ben Chaouch, Zied, Hauber, Brett, Mange, Brennan, Zhou, Mo, Christopher, Stephanie, Bardot, Dawn, Sheehan, Margaret, Donnelly, Anne, McLaughlin, Lauren, Caldwell, Brittany, Benz, Heather L., Ho, Martin, Saha, Anindita, Gwinn, Katrina, Sheldon, Murray, Lo, Andrew W.

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Working With the Food and Drug Administration's Center for Devices to Advance Regulatory Science and Medical Device Innovation: Invited Editorial von Malinauskas, Richard A., Saha, Anindita, Sheldon, Murray I.

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Development of a Patient Preference Survey for Wearable Kidney Replacement Therapy Devices von Flythe, Jennifer E, Forfang, Derek, Gedney, Nieltje, White, David M, Wilkie, Caroline, Cavanaugh, Kerri L, Harris, Raymond C, Unruh, Mark, Squillaci, Grace, West, Melissa, Mansfield, Carol, Soloe, Cindy S, Treiman, Katherine, Wood, Dallas, Hurst, Frank P, Neuland, Carolyn Y, Saha, Anindita, Sheldon, Murray, Tarver, Michelle E

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