Works matching DE "MEDICAL device approval"

Results: 146

First-in-human robot-assisted laparoscopic sigmoid resection using ANSUR surgical unit<sup>®</sup>.

Published in:

Techniques in Coloproctology, 2025, v. 29, n. 1, p. 1, doi. 10.1007/s10151-025-03183-7

By:

Hasegawa, H.;
Takeshita, N.;
Kitaguchi, D.;
Ikeda, K.;
Nishizawa, Y.;
Tsukada, Y.;
Ito, M.

Publication type:

Article

A comprehensive overview of real-world evidence in medical device approvals in the United States.

Published in:

Expert Review of Medical Devices, 2025, v. 22, n. 7, p. 767, doi. 10.1080/17434440.2025.2512041

By:

Goswami, Swarnali;
Masurkar, Prajakta P;
Kaul, Aashrey

Publication type:

Article

Evaluation of clinical data and regulatory submission characteristics for neuromodulation devices approved via the 510(k) pathway (1996–2024).

Published in:

Expert Review of Medical Devices, 2025, v. 22, n. 7, p. 739, doi. 10.1080/17434440.2025.2508869

By:

Almarie, Bassel;
Fregni, Felipe

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

GENTLO Microneedling RF Plattform der neuesten Generation.

Published in:: Kosmetische Medizin + Ästhetische Chirurgie, 2024, v. 45, n. 4, p. 272
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

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

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

Published in:

2021

By:

Çöpür, Mazlum;
Çöpür, Sidar

Publication type:

Letter

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 approves AcuFocus Kamra Inlay.

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

A Cooperative Environment for Ventricular Assist Device Development and Application: The Japanese Experience.

Published in:

2022

By:

Karigyo, Carlos;
Fonseca, Jeison;
Andrade, Aron;
Ono, Minoru

Publication type:

Letter to the Editor

The alarming consequences of workforce reductions at the FDA, EPA, NIH and CDC in the United States.

Published in:

Archives of Toxicology, 2025, v. 99, n. 6, p. 2239, doi. 10.1007/s00204-025-04065-5

By:

Dietrich, Daniel R.;
von Aulock, Sonja;
Bal-Price, Anna;
Coleman, Michael;
Cronin, Mark;
Jennings, Paul;
Mally, Angela;
Vinken, Mathieu;
Wright, Matthew;
van den Berg, Martin

Publication type:

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

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

Preface: Special Issue on Human Factors in Healthcare.

Published in:

Human Factors, 2022, v. 64, n. 1, p. 5, doi. 10.1177/00187208211073577

By:

Keebler, Joseph R.;
Salas, Eduardo;
Rosen, Michael A.;
Sittig, Dean F.;
Thomas, Eric

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

PORTABLE DENTAL RADIOGRAPHIC MACHINE.

Published in:

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

By:

Jaiswal, Saumya;
Kaur, Navpreet;
Gupta, Roopali

Publication type:

Article

Regulating Innovation with Uncertain Quality: Information, Risk, and Access in Medical Devices.

Published in:

American Economic Review, 2020, v. 110, n. 1, p. 120, doi. 10.1257/aer.20180946

By:

Grennan, Matthew;
Town, Robert J.

Publication type:

Article

Integrating Failure Mode Effect Analysis into the Medical Device Approval Process.

Published in:

Communications of the IIMA, 2010, v. 10, n. 3, p. 49

By:

Steinke, Gerhard;
Kurniawati, Vania;
Nindel-Edwards, Jim

Publication type:

Article

Medical devices need government, insurance support.

Published in:

2014

By:

Nelson, Rick

Publication type:

Editorial

Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table.

Published in:

European Heart Journal, 2025, v. 46, n. 16, p. 1469, doi. 10.1093/eurheartj/ehaf069

By:

Windecker, Stephan;
Fraser, Alan G;
Szymanski, Piotr;
Gilard, Martine;
Lüscher, Thomas F;
Abid, Leila;
Brennan, John;
Byrne, Robert;
Crotti, Lia;
Drossart, Inga;
Franke, Jennifer;
Cossellu, Mario Gabrielli;
Kirtane, Ajay J;
Kurucova, Jana;
Krucoff, Mitchell;
McGauran, Gearóid;
Myers, Patrick O;
O'Connor, Donal B;
Parma, Radosław;
Piscoi, Paul

Publication type:

Article

Quality and transparency of clinical evidence for high-risk cardiovascular medical devices: a long way to go.

Published in:

European Heart Journal, 2024, v. 45, n. 3, p. 178, doi. 10.1093/eurheartj/ehad786

By:

Szymański, Piotr;
Redberg, Rita

Publication type:

Article

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

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

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

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

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

Published in:

2017

By:

Zuckerman, Diana M.

Publication type:

Editorial

Evaluation of an FDA approved library against laboratory models of human intestinal nematode infections.

Published in:

Parasites & Vectors, 2016, v. 9, p. 1, doi. 10.1186/s13071-016-1616-0

By:

Keiser, Jennifer;
Panic, Gordana;
Adelfio, Roberto;
Cowan, Noemi;
Vargas, Mireille;
Scandale, Ivan

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

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

Transformational trajectory of paediatric circulatory support: the impact of a unique vision.

Published in:

2016

By:

Kirklin, James K.

Publication type:

Editorial

Overview of High-Risk Medical Device Innovation in Gastroenterology from 2000 to 2014: Enhancing the Pipeline.

Published in:

2016

By:

Saleem, Nasir;
Xu, Shuai

Publication type:

journal article

A Case for Randomized, Double-Blinded, Sham-Controlled Class III Medical Device Trials.

Published in:

Yale Law & Policy Review, 2015, v. 34, n. 1, p. 199

By:

Wright, Megan S.

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

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

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

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

Achievements and challenges of the Sakigake designation system in Japan.

Published in:

British Journal of Clinical Pharmacology, 2021, v. 87, n. 10, p. 4027, doi. 10.1111/bcp.14807

By:

Tanaka, Mototsugu;
Idei, Mayumi;
Sakaguchi, Hiroshi;
Kato, Ryosuke;
Sato, Daisuke;
Sawanobori, Kenji;
Kawarasaki, Shuichi;
Hata, Toshiyuki;
Yoshizaki, Asako;
Nakamura, Miki;
Ikuma, Mutsuhiro

Publication type:

Article

Treating onychomycosis with the short-pulsed 1064-nm-Nd: YAG laser: results of a prospective randomized controlled trial.

Published in:

Journal of the European Academy of Dermatology & Venereology, 2017, v. 31, n. 1, p. 175, doi. 10.1111/jdv.13798

By:

Karsai, S.;
Jäger, M.;
Oesterhelt, A.;
Weiss, C.;
Schneider, S.W.;
Jünger, M.;
Raulin, C.

Publication type:

Article

Pivotal trials of orthopedic surgical devices in the United States: predominance of two-arm non-inferiority designs.

Published in:

2017

By:

Golish, S. Raymond

Publication type:

journal article

(139) Efficacy of a New Vacuum Erection Device (Vigor 2020) for Erectile Dysfunction in a Retrospective Study in Japan.

Published in:

Journal of Sexual Medicine, 2024, v. 21, p. 1, doi. 10.1093/jsxmed/qdae002.127

By:

Shirai, M;
Sano, M;
Anno, Y;
Ishikawa, K;
Taniguchi, A;
Kure, A;
Uesaka, Y;
Nozaki, T;
Fukuhara, S;
Iwasa, A;
Kobayashi, K;
Kato, J;
Tsujimura, A

Publication type:

Article

(139) Efficacy of a New Vacuum Erection Device (Vigor 2020) for Erectile Dysfunction in a Retrospective Study in Japan.

Published in:

Journal of Sexual Medicine, 2024, v. 21, p. 1, doi. 10.1093/jsxmed/qdae002.127

By:

Shirai, M;
Sano, M;
Anno, Y;
Ishikawa, K;
Taniguchi, A;
Kure, A;
Uesaka, Y;
Nozaki, T;
Fukuhara, S;
Iwasa, A;
Kobayashi, K;
Kato, J;
Tsujimura, A

Publication type:

Article

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

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

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

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