Search Results - "Tarver, Michelle E."

Digital biomarkers: Convergence of digital health technologies and biomarkers by Vasudevan, Srikanth, Saha, Anindita, Tarver, Michelle E., Patel, Bakul

“…Increasing digitization across the healthcare continuum has revolutionized medical research, diagnostics, and therapeutics. This digitization has led to rapid…”
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Special Report: American Academy of Ophthalmology Task Force Consensus Statement for Extended Depth of Focus Intraocular Lenses by MacRae, Scott, MD, Holladay, Jack T., MD, MSEE, Glasser, Adrian, PhD, Calogero, Don, MS, Hilmantel, Gene, OD, Masket, Samuel, MD, Stark, Walter, MD, Tarver, Michelle E., MD, PhD, Nguyen, Tieuvi, PhD, Eydelman, Malvina, MD

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Considerations for addressing bias in artificial intelligence for health equity by Abràmoff, Michael D., Tarver, Michelle E., Loyo-Berrios, Nilsa, Trujillo, Sylvia, Char, Danton, Obermeyer, Ziad, Eydelman, Malvina B., Maisel, William H.

“…Health equity is a primary goal of healthcare stakeholders: patients and their advocacy groups, clinicians, other providers and their professional societies,…”
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Race and Ethnicity in Real-World Data Sources: Considerations for Medical Device Regulatory Efforts by Tarver, Michelle E.

“…Real-world evidence is increasingly being collected in our interconnected world. This information can provide insights on how medical products are impacting…”
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Special Report: American Academy of Ophthalmology Task Force Recommendations for Specular Microscopy for Phakic Intraocular Lenses by MacRae, Scott, MD, Holladay, Jack T., MD, MSEE, Hilmantel, Gene, OD, Calogero, Don, MS, Masket, Samuel, MD, Stark, Walter, MD, Glasser, Adrian, PhD, Rorer, Eva, MD, Tarver, Michelle E., MD, PhD, Nguyen, Tieuvi, PhD, Eydelman, Malvina, MD

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Special Report: American Academy of Ophthalmology Task Force Summary Statement for Measurement of Tilt, Decentration, and Chord Length by Holladay, Jack T., MD, MSEE, Calogero, Don, MS, Hilmantel, Gene, OD, Glasser, Adrian, PhD, MacRae, Scott, MD, Masket, Samuel, MD, Stark, Walter, MD, Tarver, Michelle E., MD, PhD, Nguyen, Tieuvi, PhD, Eydelman, Malvina, MD

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Inclusion of patient-reported outcome instruments in US FDA medical device marketing authorizations by Matts, Sophia T., Webber, Christina M., Bocell, Fraser D., Caldwell, Brittany, Chen, Allen L., Tarver, Michelle E.

“…Background The U.S. Food and Drug Administration encourages the incorporation of the patient voice throughout the medical device total product lifecycle. This…”
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Patient-reported outcomes and medical device evaluation: from conception to implementation by Webber, Christina M., Caldwell, Brittany, Bocell, Fraser D., Saha, Anindita, Tarver, Michelle E.

“…Background The insights gleaned from patient-reported outcomes (PROs) have implications across the healthcare ecosystem, from clinical investigations to…”
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Special Report: The American Academy of Ophthalmology Task Force Consensus Statement on Adverse Events with Intraocular Lenses by Masket, Samuel, MD, Rorer, Eva, MD, Stark, Walter, MD, Holladay, Jack T., MD, MSEE, MacRae, Scott, MD, Tarver, Michelle E., MD, PhD, Glasser, Adrian, PhD, Calogero, Don, MS, Hilmantel, Gene, OD, Nguyen, Tieuvi, PhD, Eydelman, Malvina, MD

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Do patient-reported outcome measures measure up? A qualitative study to examine perceptions and experiences with heart failure proms among diverse, low-income patients by Davis, Jonathan, Olazo, Kristan, Sierra, Maribel, Tarver, Michelle E., Caldwell, Brittany, Saha, Anindita, Lisker, Sarah, Lyles, Courtney, Sarkar, Urmimala

“…Background The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a Patient-Reported Outcome Measure (PROM) used to evaluate the health status of patients with…”
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Special Report: The American Academy of Ophthalmology Task Force for Developing Novel End Points for Premium Intraocular Lenses Introduction by Lum, Flora, MD, Holladay, Jack T., MD, MSEE, Glasser, Adrian, PhD, MacRae, Scott, MD, Masket, Samuel, MD, Stark, Walter, MD, Rorer, Eva, MD, Tarver, Michelle E., MD, PhD, Calogero, Don, MS, Hilmantel, Gene, OD, Nguyen, Tieuvi, PhD, Eydelman, Malvina, MD

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The Food and Drug Administration's Proactive Toxic Anterior Segment Syndrome Program by Eydelman, Malvina B., MD, Tarver, Michelle E., MD, PhD, Calogero, Don, MS, Buchen, Shelley Y., MS, Alexander, Kesia Y., PhD

“…Toxic anterior segment syndrome (TASS) is a rare inflammatory condition usually observed within the first 48 hours after uncomplicated anterior segment…”
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Integrating Patient Perspectives into Medical Device Regulatory Decision Making to Advance Innovation in Kidney Disease by Tarver, Michelle E, Neuland, Carolyn

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Evaluation of Intraocular Reactivity to Metallic and Ethylene Oxide Contaminants of Medical Devices in a Rabbit Model by Calogero, Don, MS, Buchen, Shelley Y., MS, Tarver, Michelle E., MD, PhD, Hilmantel, Gene, OD, MS, Lucas, Anne D., PhD, Eydelman, Malvina B., MD

“…Objective To evaluate the intraocular reactivity to metallic and ethylene oxide (EO) contaminants of ophthalmic devices in rabbits. Design Two experimental…”
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Special Commentary: Supporting Innovation for Safe and Effective Minimally Invasive Glaucoma Surgery by Caprioli, Joseph, MD, Kim, Julie H., MD, Friedman, David S., MD, PhD, Kiang, Tina, PhD, Moster, Marlene R., MD, Parrish, Richard K., MD, Rorer, Eva M., MD, Samuelson, Thomas, MD, Tarver, Michelle E., MD, PhD, Singh, Kuldev, MD, MPH, Eydelman, Malvina B., MD

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Novel medical devices to address the opioid crisis by Angelone, Leonardo M., Capanna, Kathryn, Gray, Tracy, Gutowski, Stacie, Kotarek, Joseph, Koustova, Elena, Pollock, Jonathan, Rorer, Eva, Tarver, Michelle E., Yi, Jisun

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Evaluation of Intraocular Reactivity to Organic Contaminants of Ophthalmic Devices in a Rabbit Model by Buchen, Shelley Y., MS, Calogero, Don, MS, Tarver, Michelle E., MD, PhD, Hilmantel, Gene, OD, MS, Tang, Xing, PhD, Eydelman, Malvina B., MD

“…Objective To evaluate the intraocular reactivity to organic contaminants of ophthalmic devices in the rabbit. Design Experimental animal study. Participants…”
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Symptoms and Satisfaction of Patients in the Patient-Reported Outcomes With Laser In Situ Keratomileusis (PROWL) Studies by Eydelman, Malvina, Hilmantel, Gene, Tarver, Michelle E, Hofmeister, Elizabeth M, May, Jeanine, Hammel, Keri, Hays, Ron D, Ferris, 3rd, Frederick

“…Patient-reported outcomes should be collected using validated questionnaires prior to and following laser in situ keratomileusis (LASIK) surgery. To report the…”
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Integrating the Voice of the Patient Into the Medical Device Regulatory Process Using Patient Preference Information by Benz, Heather L., Saha, Anindita, Tarver, Michelle E.

“…The US Food and Drug Administration is one of several US and global agencies making strides to incorporate patient preference information (PPI) into its…”
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Patient-Reported Outcomes for Minimally Invasive Glaucoma Surgery by Singh, Kuldev, Spaeth, George L., Hays, Ron D., Parke, David W., Tarver, Michelle E., Eydelman, Malvina

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