Works matching DE "MEDICAL device approval"

Results: 140

An exploratory study of product development in emerging economies: evidence from medical device testing in India.

Published in:

R&D Management, 2018, v. 48, n. 4, p. 485, doi. 10.1111/radm.12324

By:

Gupta, Budhaditya;
Thomke, Stefan

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

Regulatory Science, and How Device Regulation Will Shape Our Future.

Published in:

Pediatric Cardiology, 2020, v. 41, n. 3, p. 469, doi. 10.1007/s00246-020-02296-0

By:

Ibrahim, Nicole;
Gillette, Nicole;
Patel, Hetal;
Peiris, Vasum

Publication type:

Article

Photobiomodulation therapy for androgenetic alopecia: A clinician’s guide to home-use devices cleared by the Federal Drug Administration.

Published in:

Journal of Cosmetic & Laser Therapy, 2018, v. 20, n. 3, p. 159, doi. 10.1080/14764172.2017.1383613

By:

Dodd, Erin M.;
Winter, Margo A.;
Hordinsky, Maria K.;
Sadick, Neil S.;
Farah, Ronda S.

Publication type:

Article

FROM THE HILL.

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

THE WEATHERVANE.

Published in:

Hawaii Journal of Medicine & Public Health, 2016, v. 75, n. 11, p. 362

By:

Stodd, Russell T.

Publication type:

Article

An inexpensive and effective device to manage nasal Raynaud and rosacea overlap symptoms.

Published in:

Clinical & Experimental Dermatology, 2024, v. 49, n. 12, p. 1709, doi. 10.1093/ced/llae265

By:

Yan, Chi Kit;
Madan, Vishal

Publication type:

Article

Tackling a Mountain of Applications: The CFDA's New Plans to Accelerate the Review Process for Medical Devices.

Published in:: China Business Review, 2016, p. 1
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

Marketing authorization of medical devices in China.

Published in:

Journal of Commercial Biotechnology, 2016, v. 22, n. 1, p. 15, doi. 10.5912/jcb720

By:

Weifan Zhang;
Liu, Rebecca;
Chatwin, Chris

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

Navigating the evolving landscape: A review of clinical trial regulations in India.

Published in:

Journal of Generic Medicines, 2025, v. 21, n. 1, p. 22, doi. 10.1177/17411343241277439

By:

Jhuria, Ajit;
Nagpal, Diksha;
Verma, Ravinder;
Mittal, Vineet;
Budhwar, Vikas;
Kaushik, Deepak

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

Artificial intelligence in abdominal and pelvic ultrasound imaging: current applications.

Published in:

Abdominal Radiology, 2025, v. 50, n. 4, p. 1775, doi. 10.1007/s00261-024-04640-x

By:

Cai, Lie;
Pfob, André

Publication type:

Article

In the Right Light: Photodynamic Inactivation of Microorganisms Using a LED-Based Illumination Device Tailored for the Antimicrobial Application.

Published in:

Antibiotics (2079-6382), 2020, v. 9, n. 1, p. 13, doi. 10.3390/antibiotics9010013

By:

Hasenleitner, Martina;
Plaetzer, Kristjan

Publication type:

Article

Medical regulation of cognitive enhancement devices: some concerns.

Published in:

Journal of Law & the Biosciences, 2014, v. 1, n. 3, p. 334, doi. 10.1093/jlb/lsu020

By:

King, Mike;
Gavaghan, Colin;
McMillan, John

Publication type:

Article

Buttressing regulation of cognitive enhancement devices with principles of harm reduction.

Published in:

Journal of Law & the Biosciences, 2014, v. 1, n. 3, p. 322, doi. 10.1093/jlb/lsu018

By:

Fitz, Nicholas S.;
Reiner, Peter B.

Publication type:

Article

Regulation of cognitive enhancement devices: commentary.

Published in:

2014

By:

Johnson, Reuben;
Gillett, Grant;
Snelling, Jeanne

Publication type:

Opinion

The brain, cognitive enhancement devices, and European regulation.

Published in:

Journal of Law & the Biosciences, 2014, v. 1, n. 3, p. 340, doi. 10.1093/jlb/lsu019

By:

Kuersten, Andreas;
Hamilton, Roy H.

Publication type:

Article

Trading Safety for Innovation and Access: An Empirical Evaluation of the FDA's Premarket Approval Process.

Published in:

Brigham Young University Law Review, 2017, v. 2017, n. 5, p. 991

By:

Horvath, George

Publication type:

Article

Trigeminal nerve stimulation: a recently approved treatment approach in attention deficit hyperactivity disorder.

Published in:

2021

By:

Çöpür, Mazlum;
Çöpür, Sidar

Publication type:

Letter

Medical devices need government, insurance support.

Published in:

2014

By:

Nelson, Rick

Publication type:

Editorial

Is the Wearable Cardioverter-defibrillator Ready for Prime Time?

Published in:

Clinical Cardiology Alert, 2016, v. 35, n. 11, p. 85

By:

Crawford, Michael

Publication type:

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

Nonsurgical body contouring with energy devices.

Published in:

Medicine Today, 2023, v. 24, n. 9, p. 49

By:

SEBARATNAM, DESHAN FRANK;
PATEL, ANITA;
ADRIAN LIM

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

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

Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements.

Published in:

2017

By:

Zheng, Sarah Y.;
Dhruva, Sanket S.;
Redberg, Rita F.

Publication type:

journal article

Monitoring Medical Devices: Missed Warning Signs Within Existing Data.

Published in:

2017

By:

Ibrahim, Andrew M.;
Dimick, Justin B.

Publication type:

journal article

In-home, Over-the-counter Sleep Apnea Sensor on the Horizon.

Published in:

2017

By:

Abbasi, Jennifer

Publication type:

journal article

Biotech Innovations.

Published in:

JAMA: Journal of the American Medical Association, 2017, v. 317, n. 22, p. 2271

By:

Abbasi, Jennifer

Publication type:

Article

Benefit-Risk Assessments at the US Food and Drug Administration: Finding the Balance.

Published in:

2017

By:

Califf, Robert M.

Publication type:

journal article

Priorities for Improving Hearing Health Care for Adults: A Report From the National Academies of Sciences, Engineering, and Medicine.

Published in:

2016

By:

Lin, Frank R.;
Hazzard, William R.;
Blazer, Dan G.

Publication type:

journal article

The $9 Herpes Test.

Published in:

JAMA: Journal of the American Medical Association, 2015, v. 314, n. 7, p. 662, doi. 10.1001/jama.2015.9405

By:

Voelker, Rebecca

Publication type:

Article

Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011.

Published in:

JAMA: Journal of the American Medical Association, 2015, v. 314, n. 6, p. 604, doi. 10.1001/jama.2015.8761

By:

Rathi, Vinay K.;
Krumholz, Harlan M.;
Masoudi, Frederick A.;
Ross, Joseph S.

Publication type:

Article

Temporary Heart Pump Approved.

Published in:

JAMA: Journal of the American Medical Association, 2015, v. 313, n. 19, p. 1898, doi. 10.1001/jama.2015.4555

By:

Rubin, Rita

Publication type:

Article

"ResQCPR" Could Help Prevent Cardiac Arrest Deaths.

Published in:

JAMA: Journal of the American Medical Association, 2015, v. 313, n. 15, p. 1507, doi. 10.1001/jama.2015.3307

By:

Rubin, Rita

Publication type:

Article

Device Approved for Some Patients With Atrial Fibrillation.

Published in:

JAMA: Journal of the American Medical Association, 2015, v. 313, n. 15, p. 1507, doi. 10.1001/jama.2015.3001

By:

Rubin, Rita

Publication type:

Article

The 32<sup>nd</sup> Annual Gravens Conference on the Environment of Care for High Risk Newborns, in collaboration with the March of Dimes.

Published in:: Neonatology Today, 2018, v. 13, n. 10, p. 36
Publication type:: Article

Eyes on New Product Development.

Published in:

2017

By:

Novack, Gary D.

Publication type:

journal 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

FDA APPROVAL OF DRUGS AND DEVICES: PREEMPTION OF STATE LAWS FOR "PARALLEL" TORT CLAIMS.

Published in:

Journal of Health Care Law & Policy, 2015, v. 18, n. 1, p. 1

By:

BOUMIL, MARCIA

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

Reply to "Comment on micro‐ and nanorobots for biofilm eradication".

Published in:

APMIS, 2024, v. 132, n. 11, p. 757, doi. 10.1111/apm.13460

By:

Pathoor, Naji Naseef;
Ganesh, Pitchaipillai Sankar

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

THE PATHWAY TO FASTER CURES.

Published in:

Freeman: Ideas on Liberty, 2015, p. 2

By:

Madden, Bartley J.

Publication type:

Article

Getting the Balance of Safety and Speed of Medical Device Approval Right.

Published in:

Annals of Internal Medicine, 2024, v. 177, n. 11, p. 1582, doi. 10.7326/ANNALS-24-01840

By:

Emanuel, Ezekiel J.

Publication type:

Article

FDA CLARIFIES RESEARCH POLICIES TO FACILITATE NEW DRUG DEVELOPMENT.

Published in:

Applied Clinical Trials, 2018, v. 27, n. 12, p. 6

By:

Wechsler, Jill

Publication type:

Article