Works matching DE "MEDICAL device approval"

Results: 140

REGULATING BLACK-BOX MEDICINE.

Published in:

Michigan Law Review, 2017, v. 116, n. 3, p. 421, doi. 10.36644/mlr.116.3.regulating

By:

Price II, W. Nicholson

Publication type:

Article

FROM THE HILL.

Published in:: Issues in Science & Technology, 2011, v. 27, n. 4, p. 23
Publication type:: Article

A Major Shortcoming in the Public Health Legacy of the Obama Administration.

Published in:

2017

By:

Zuckerman, Diana M.

Publication type:

Editorial

FDA approves AcuFocus Kamra Inlay.

Published in:: Optometry Times, 2015, v. 7, n. 5, p. 36
Publication type:: Article

Leveraging Real-World Evidence Derived from Patient Registries for Premarket Medical Device Regulatory Decision-Making.

Published in:

Statistics in Biopharmaceutical Research, 2018, v. 10, n. 2, p. 98, doi. 10.1080/19466315.2017.1422436

By:

Yue, Lilly Q.

Publication type:

Article

Statistical Methods for Clinical Validation of Follow-On Companion Diagnostic Devices via an External Concordance Study.

Published in:

Statistics in Biopharmaceutical Research, 2016, v. 8, n. 3, p. 355, doi. 10.1080/19466315.2016.1202859

By:

Li, Meijuan

Publication type:

Article

An update on the validation of whole slide imaging systems following FDA approval of a system for a routine pathology diagnostic service in the United States.

Published in:

Biotechnic & Histochemistry, 2017, v. 92, n. 6, p. 381, doi. 10.1080/10520295.2017.1355476

By:

Boyce, BF

Publication type:

Article

The impact of regulatory review time on incremental and radical innovation: evidence from the high-risk medical device market.

Published in:

Journal of Regulatory Economics, 2020, v. 57, n. 2, p. 134, doi. 10.1007/s11149-020-09401-4

By:

Onur, Ilke;
Söderberg, Magnus

Publication type:

Article

Informing the US FDA's Software as a Medical Device Approval Process's Design: EU, Canada and UK Case Studies.

Published in:

AIRe: Journal of AI Law & Regulation, 2025, v. 2, n. 1, p. 4, doi. 10.21552/aire/2025/1/4

By:

Sankararaman, Kedharnath;
Uter, Jordan;
Faveri, Benjamin

Publication type:

Article

Harmonizing Standards and Incentives in Medical Device Regulation: Lessons Learned from the Parallel Review Pathway.

Published in:

Journal of Law, Medicine & Ethics, 2018, v. 46, n. 4, p. 1034, doi. 10.1177/1073110518822005

By:

Holtzman, Jessica N.;
Kramer, Daniel B.

Publication type:

Article

Why There Is No Obligation to Participate in Clinical Research.

Published in:

Journal of Law, Medicine & Ethics, 2017, v. 45, n. 3, p. 327, doi. 10.1177/1073110517737530

By:

Yarborough, Mark

Publication type:

Article

Profile of the Implantable Medical Devices Registered in Malaysia between the Year 2013 to 2017.

Published in:

Malaysian Journal of Medicine & Health Sciences, 2021, v. 17, p. 85

By:

Anamalai, Sunthara Murthi;
Kamaldin, Jahangir;
Hambali, Ahmad Shariff

Publication type:

Article

COMMENTARY.

Published in:

Neurointervention, 2018, v. 13, n. 1, p. 31

By:

Chang-Woo Ryu

Publication type:

Article

The next medical device scandal: Medical device files - my personal view (Part 2).

Published in:

Medical Writing, 2019, v. 28, n. 2, p. 104

By:

Doerr, Beatrix

Publication type:

Article

An Interview with Dr Bassil Akra.

Published in:

2017

By:

Akra, Bassil

Publication type:

Interview

Medical devices.

Published in:: Medical Writing, 2017, v. 26, n. 2, p. 73
Publication type:: Article

The New EU Medical Device Regulation: New opportunities for regulatory writers.

Published in:

Medical Writing, 2017, v. 26, n. 2, p. 72

By:

Billiones, Raquel

Publication type:

Article

Does standardisation improve animal testing of medical devices?

Published in:

Medical Writing, 2017, v. 26, n. 2, p. 35

By:

Patel, Jayna

Publication type:

Article

Transparency -- left to its own devices until now.

Published in:

Medical Writing, 2017, v. 26, n. 2, p. 29

By:

Dunlevy, Fiona

Publication type:

Article

Medical Device Regulation: A necessary step towards more patient and user safety.

Published in:

Medical Writing, 2017, v. 26, n. 2, p. 25

By:

Frumento, Claudia

Publication type:

Article

New EU medical device regulations: Impact on the MedTech sector.

Published in:

Medical Writing, 2017, v. 26, n. 2, p. 20

By:

Behan, Robert;
Watson, Mark;
Pandit, Abhay

Publication type:

Article

Correlation Between Conditional Approval and Customized Bone Implant Devices.

Published in:

Orthopaedic Surgery, 2019, v. 11, n. 1, p. 10, doi. 10.1111/os.12415

By:

Guo, Xiao‐lei;
Liu, Bin;
Lu, Zhong

Publication type:

Article

PORTABLE DENTAL RADIOGRAPHIC MACHINE.

Published in:

Guident, 2020, v. 14, n. 1, p. 53

By:

Jaiswal, Saumya;
Kaur, Navpreet;
Gupta, Roopali

Publication type:

Article

Major Pharmaceutical Conferences and Courses: February 2024 to March 2024.

Published in:: 2023
Publication type:: Proceeding

INTRODUCING A FAIRNESS CHECKPOINT FOR DATA QUALITY AND EVIDENCE DURING REGULATORY REVIEW OF AI/ML-ENABLED MEDICAL DEVICES.

Published in:

Houston Journal of Health Law & Policy, 2025, v. 24, n. 1, p. 191

By:

Shabani, Mahsa;
Rahimzadeh, Vasiliki

Publication type:

Article

Integration of new technology into clinical practice after FDA approval.

Published in:

2016

By:

Govil, Ashul;
Hao, Steven;
Hao, Steven C

Publication type:

journal article

Magnetic surgery: first U.S. experience with a novel device.

Published in:

2018

By:

Haskins, Ivy N.;
Strong, Andrew T.;
Allemang, Matthew T.;
Bencsath, Kalman P.;
Rodriguez, John H.;
Kroh, Matthew D.

Publication type:

journal article

Bridge-Enhanced ACL Repair: A Review of the Science and the Pathway Through FDA Investigational Device Approval.

Published in:

Annals of Biomedical Engineering, 2015, v. 43, n. 3, p. 805, doi. 10.1007/s10439-015-1257-z

By:

Proffen, Benedikt;
Perrone, Gabriel;
Roberts, Gordon;
Murray, Martha

Publication type:

Article

Recent Progress in the Field of Artificial Organs.

Published in:: Artificial Organs, 2025, v. 49, n. 5, p. 725, doi. 10.1111/aor.14990
Publication type:: Article

Recent Progress in Artificial Organs.

Published in:: Artificial Organs, 2025, v. 49, n. 4, p. 537, doi. 10.1111/aor.14968
Publication type:: Article

Global Regulatory Challenges for Medical Devices: Impact on Innovation and Market Access.

Published in:

Applied Sciences (2076-3417), 2024, v. 14, n. 20, p. 9304, doi. 10.3390/app14209304

By:

Amaral, Carolina;
Paiva, Maria;
Rodrigues, Ana Rita;
Veiga, Francisco;
Bell, Victoria

Publication type:

Article

What will myopia control look like in 2034? New long-term findings illuminate the future of DIMS spectacle lenses.

Published in:

Optometry Times, 2024, v. 16, n. 12, p. 30

By:

Hayes, Hattie;
Lam, Carly

Publication type:

Article

FDA approves eye-tracking test to detect concussion.

Published in:: Optometry Times, 2019, v. 11, n. 2, p. 23
Publication type:: Article

Dompé receives FDA approval of Oxervate.

Published in:: Optometry Times, 2018, v. 10, n. 9, p. 30
Publication type:: Article

Adapting modeling and simulation credibility standards to computational systems biology.

Published in:

Journal of Translational Medicine, 2023, v. 21, n. 1, p. 1, doi. 10.1186/s12967-023-04290-5

By:

Tatka, Lillian T.;
Smith, Lucian P.;
Hellerstein, Joseph L.;
Sauro, Herbert M.

Publication type:

Article

21ST CENTURY CURES ACT: THE PROBLEM WITH PREEMPTION IN LIGHT OF DEREGULATION.

Published in:

University of Michigan Journal of Law Reform, 2019, v. 52, n. 4, p. 801, doi. 10.36646/mjlr.52.3.century

By:

Andersen, Megan C.

Publication type:

Article

Is rTMS Ready for Primetime?

Published in:

Canadian Journal of Psychiatry, 2021, v. 66, n. 10, p. 873, doi. 10.1177/07067437211016238

By:

Malhi, Gin S.;
Bell, Erica;
Outhred, Tim;
Singh, Ajeet B.;
Hopwood, Malcom;
Mulder, Roger;
Bassett, Darryl;
Mannie, Zola

Publication type:

Article

Laser devices for vaginal rejuvenation: effectiveness, regulation and marketing.

Published in:

Canadian Medical Association Journal (CMAJ), 2023, v. 195, n. 5, p. E195, doi. 10.1503/cmaj.221208

By:

Welk, Blayne;
Kelly, Erin

Publication type:

Article

Left atrial appendage occlusion: 2016 in review.

Published in:

2017

By:

J. Ramos Ramirez, Manuel;
Young, Bonnie;
Harjai, Kishore;
Mascarenhas, Vernon;
Vijayaraman, Pugazhendhi

Publication type:

journal article

Market approval processes for new types of spinal devices: challenges and recommendations for improvement.

Published in:

2016

By:

Bisschop, Arno;
Tulder, Maurits;
van Tulder, Maurits W

Publication type:

journal article

DISEÑO Y CONSTRUCCIÓN DE EQUIPO DE VENTILACIÓN MECÁNICA AUTOMATIZADA PARA ASISTIR INSUFICIENCIA RESPIRATORIA.

Published in:

Ingenius, Revista Ciencia y Tecnología, 2022, n. 27, p. 17, doi. 10.17163/ings.n27.2022.02.

By:

Carrillo, Gilberto;
Gómez, Mauricio;
Rodas, Jaime;
Pimentel, Rafael

Publication type:

Article

Single-center, noninterventional clinical trial to assess the safety, efficacy, and tolerability of a dimeticone-based medical device in facilitating the removal of scales after topical application in patients with psoriasis corporis or psoriasis capitis.

Published in:

Psoriasis: Targets & Therapy, 2017, v. 7, p. 41, doi. 10.2147/PTT.S130295

By:

Hengge, Ulrich R.;
Röschmann, Kristina;
Candler, Henning

Publication type:

Article

Demographic Characteristics of Participants in Trials Essential to US Food and Drug Administration Vaccine Approvals, 2010–2020.

Published in:

2022

By:

Zhang, Audrey D.;
Puthumana, Jeremy;
Egilman, Alexander C.;
Schwartz, Jason L.;
Ross, Joseph S.

Publication type:

Letter

HATCH-WAXMAN AND MEDICAL DEVICES.

Published in:

William Mitchell Law Review, 2014, v. 40, n. 4, p. 1407

By:

Wallenfelt, Brian P.

Publication type:

Article

THERE'S A HOLE IN MY BUCKET DEAR LIZA, DEAR LIZA: THE 30-YEAR ANNIVERSARY OF THE HATCHWAXMAN ACT: RESOLVED AND UNRESOLVED GAPS AND COURT-DRIVEN POLICY GAP FILLING.

Published in:

William Mitchell Law Review, 2014, v. 40, n. 4, p. 1307

By:

Upadhye, Shashank

Publication type:

Article

THE INTERPLAY BETWEEN FDA AND PATENT LAW: INFUSING ORGANIZATIONAL KNOWLEDGE FOR MEDICAL DEVICE COMPANIES.

Published in:

William Mitchell Law Review, 2013, v. 39, n. 4, p. 1176

By:

Arora, Suneel;
Christman, Timothy J.;
Mays, Ashley N.;
Schmidt, Andrew

Publication type:

Article

BE CAREFUL WHAT YOU ASK FOR: THE FDA'S DENIALS OF CITIZEN PETITIONS CONFIRMS THERE IS NO SUCH THING AS A LIMITED PREMARKET APPROVAL.

Published in:

William Mitchell Law Review, 2013, v. 39, n. 4, p. 1157

By:

Schultz, David T.;
Aberson, D. Scott

Publication type:

Article

THE PUZZLE OF PARALLEL CLAIMS, PREEMPTION, AND PLEADING THE PARTICULARS.

Published in:

William Mitchell Law Review, 2013, v. 39, n. 4, p. 1034

By:

Prince, J. David

Publication type:

Article

FOREWORD: IS IT TIME FOR AN ABBREVIATED PREMARKET APPROVAL FOR MEDICAL DEVICES?

Published in:

William Mitchell Law Review, 2013, v. 39, n. 4, p. 1026

By:

Wallenfelt, Brian P.

Publication type:

Article

THE INTERPLAY BETWEEN FDA AND PATENT LAW: INFUSING ORGANIZATIONAL KNOWLEDGE FOR MEDICAL DEVICE COMPANIES.

Published in:

William Mitchell Law Review, 2012, v. 38, n. 4, p. 1176

By:

Arora, Suneel;
Christman, Timothy J.;
Mays, Ashley N.;
Schmidt, Andrew

Publication type:

Article