Works about NEW product development laws

Results: 505

Audio Highlights: June 6, 2025.

Published in:: JAMA: Journal of the American Medical Association, 2025, v. 334, n. 1, p. e2418864, doi. 10.1001/jama.2024.18864
Publication type:: Article

How AI is used in FDA-authorized medical devices: a taxonomy across 1,016 authorizations.

Published in:

NPJ Digital Medicine, 2025, v. 8, n. 1, p. 1, doi. 10.1038/s41746-025-01800-1

By:

Singh, Rohan;
Bapna, Monika;
Diab, Abdul Rahman;
Ruiz, Emily S.;
Lotter, William

Publication type:

Article

Disclosed Industry Funding Does Not Increase Positive Outcomes in Studies on Suture Button Fixation for Ankle Syndesmotic Injuries: A Systematic Review.

Published in:

Foot & Ankle Orthopaedics, 2025, v. 10, n. 2, p. 1, doi. 10.1177/24730114251341305

By:

Feingold, Cailan L.;
Lin, Eric H.;
Subhash, Ajith K.;
Tercyak, Samuel C.;
Jagasia, Aidan A.;
Tan, Eric W.;
Peterson, Alexander B.;
Liu, Joseph N.

Publication type:

Article

The Promise and Peril of Over-the-Counter Hearing Aids: Thoughts on Navigating the Current OTC Landscape.

Published in:

Audiology Today, 2025, v. 37, n. 4, p. 8

By:

TAYLOR, BRIAN

Publication type:

Article

Latest news: FLASH-UK study, tirzepatide marketing authorisation, Dexcom G7 launch and GLP-1 RA shortages: Stay abreast of the latest news that could impact diabetes nursing.

Published in:: Journal of Diabetes Nursing, 2022, v. 26, n. 5, p. 1
Publication type:: Article

Intrauterine hemostatic device: Uterine contraction to expel a device a fundamental mechanism?

Published in:

Journal of Obstetrics & Gynaecology Research, 2024, v. 50, n. 1, p. 141, doi. 10.1111/jog.15835

By:

Matsubara, Shigeki

Publication type:

Article

PATENTING PLANT-BASED INNOVATIONS.

Published in:

Innovation, 2006, v. 6, n. 2, p. 50

By:

Ong, Burton

Publication type:

Article

The issue of whether studies involving off-label use of new devices need to be replaced by controlled studies.

Published in:

2010

By:

Henkes, Hans

Publication type:

Letter

Response to 'Critical comments and questions to the publication 'Getgood A, Collins B, Slynarski K, Kurowska E, Parker D, Engebretsen L, Macdonald PB, Litchfield R 2011 Short-term safety and efficacy of a novel high tibial osteotomy system: a case controlled study''

Published in:

2013

By:

Getgood, Alan;
Litchfield, Robert

Publication type:

Letter

How to integrate new technologies into daily practice: The clinician perspective.

Published in:

Journal of Wound Management, 2021, v. 22, n. 2, p. 7, doi. 10.35279/jowm202107.02

By:

Téot, Luc;
Meaume, Sylvie;
Kerihuel, Jean Charles

Publication type:

Article

The illusion of safety: A report to the FDA on AI healthcare product approvals.

Published in:

PLoS Digital Health, 2025, v. 4, n. 6, p. 1, doi. 10.1371/journal.pdig.0000866

By:

Abulibdeh, Rawan;
Celi, Leo Anthony;
Sejdić, Ervin

Publication type:

Article

Quantification of US Food and Drug Administration Premarket Approval Statements for High-Risk Medical Devices With Pediatric Age Indications.

Published in:

JAMA Network Open, 2021, v. 4, n. 6, p. e2112562, doi. 10.1001/jamanetworkopen.2021.12562

By:

Lee, Samuel J.;
Cho, Lauren;
Klang, Eyal;
Wall, James;
Rensi, Stefano;
Glicksberg, Benjamin S.

Publication type:

Article

The Scarcity of Approved Pediatric High-Risk Medical Devices.

Published in:

2021

By:

Espinoza, Juan C.

Publication type:

Opinion

Risk of Recall Among Medical Devices Undergoing US Food and Drug Administration 510(k) Clearance and Premarket Approval, 2008-2017.

Published in:

JAMA Network Open, 2021, v. 4, n. 5, p. e217274, doi. 10.1001/jamanetworkopen.2021.7274

By:

Dubin, Jonathan R.;
Simon, Stephen D.;
Norrell, Kirsten;
Perera, Jacob;
Gowen, Jacob;
Cil, Akin

Publication type:

Article

Postmarket Clinical Evidence for High-Risk Therapeutic Medical Devices Receiving Food and Drug Administration Premarket Approval in 2010 and 2011.

Published in:

JAMA Network Open, 2020, v. 3, n. 8, p. e2014496, doi. 10.1001/jamanetworkopen.2020.14496

By:

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

Publication type:

Article

The Changing Characteristics of Technologies Covered by Medicare's New Technology Add-on Payment Program.

Published in:

JAMA Network Open, 2020, v. 3, n. 8, p. e2012569, doi. 10.1001/jamanetworkopen.2020.12569

By:

Manz, Christopher R.;
Bekelman, Justin E.;
Doshi, Jalpa A.

Publication type:

Article

Effects of an extended MRI approval of an implantable spinal cord stimulation device on compliance with manufacturer's recommendations.

Published in:

Pain Practice, 2025, v. 25, n. 4, p. 1, doi. 10.1111/papr.70022

By:

Reining, Marco;
Winkler, Dirk;
Kirchhof, Klaus;
Boettcher, Joachim;
Kretzschmar, Michael

Publication type:

Article

Magnetic resonance imaging scans in patients with dorsal root ganglion stimulation.

Published in:

Pain Practice, 2021, v. 21, n. 8, p. 924, doi. 10.1111/papr.13067

By:

Reining, Marco;
Winkler, Dirk;
Boettcher, Joachim;
Meixensberger, Juergen;
Kretzschmar, Michael

Publication type:

Article

CLOSING THE LOOPHOLES IN THE REGULATION OF MEDICAL DEVICES: THE NEED FOR CONGRESS TO REEVALUATE MEDICAL DEVICE REGULATION.

Published in:

Health Matrix: Journal of Law-Medicine, 2007, v. 17, n. 2, p. 441

By:

VanBuren, Michael

Publication type:

Article

The subepidermal moisture scanner: the technology explained.

Published in:

Journal of Wound Care, 2020, v. 29, n. Sup2c, p. S10, doi. 10.12968/jowc.2020.29.Sup2c.S10

By:

Gefen, Amit;
Ross, Graham

Publication type:

Article

Awareness, attitude, and practice of materiovigilance among medical professionals at a tertiary care institute of national importance: A cross-sectional study.

Published in:

Perspectives in Clinical Research, 2022, v. 13, n. 2, p. 94, doi. 10.4103/picr.PICR_187_19

By:

Meher, Bikash;
Padhy, Biswa;
Srinivasan, Anand;
Mohanty, Rashmi

Publication type:

Article

Effect of educational intervention on awareness of pharmacovigilance among medical undergraduates in a tertiary care teaching hospital.

Published in:

Perspectives in Clinical Research, 2020, v. 11, n. 2, p. 92, doi. 10.4103/picr.PICR_16_19

By:

Kalikar, Mrunalini;
Dakhale, Ganesh;
Shrirao, Mayur

Publication type:

Article

Expert Recommendations on Frequency of Utilization of Common Laboratory Tests in Medical Inpatients: a Canadian Consensus Study.

Published in:

2019

By:

Ambasta, Anshula;
Pancic, Stefana;
Wong, Brian M.;
Lee, Todd;
McCaughey, Deirdre;
Ma, Irene W. Y.

Publication type:

journal article

Who is responsible for evaluating the safety and effectiveness of medical devices? The role of independent technology assessment.

Published in:

2008

By:

Feldman, Mitchell D.;
Petersen, Amy J.;
Karliner, Leah S.;
Tice, Jeffrey A.

Publication type:

journal article

Trial registration for public trust: making the case for medical devices.

Published in:

2008

By:

Sim, Ida

Publication type:

journal article

Precision diagnosis: a view of the clinical decision support systems (CDSS) landscape through the lens of critical care.

Published in:

2017

By:

Belard, Arnaud;
Buchman, Timothy;
Forsberg, Jonathan;
Potter, Benjamin;
Dente, Christopher;
Kirk, Allan;
Elster, Eric;
Potter, Benjamin K;
Dente, Christopher J

Publication type:

journal article

Vagus Nerve Stimulation with Essential Oils: A Brief Review.

Published in:

International Journal of Professional Holistic Aromatherapy, 2023, v. 11, n. 4, p. 37

By:

Mortensen, Jamie

Publication type:

Article

Historia de los dispositivos de administración de insulina.

Published in:

Revista Mexicana de Endocrinología, Metabolismo y Nutrición, 2021, v. 8, p. 29, doi. 10.24875/RME.M21000016

By:

Ferreira-Hermosillo, Aldo;
Elías-López, Daniel

Publication type:

Article

Government Support of Meaningful Drug and Device Innovation: Pathways and Challenges.

Published in:

Journal of Law, Medicine & Ethics, 2023, v. 51, p. 7, doi. 10.1017/jme.2024.21

By:

Kesselheim, Aaron S.

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

Public Participation in Drafting of the 21st Century Cures Act.

Published in:

Journal of Law, Medicine & Ethics, 2017, v. 45, n. 2, p. 212, doi. 10.1177/1073110517720650

By:

Hwang, Thomas J.;
Sachs, Rachel E.;
Kesselheim, Aaron S.

Publication type:

Article

Endoscopic Approaches for the Treatment of Obesity: Fact or Fiction?

Published in:

2011

By:

DeLegge, Mark H.

Publication type:

Journal Article

Life Cycle of Medical Product Rules Issued by the US Food and Drug Administration.

Published in:

Journal of Health Politics, Policy & Law, 2014, v. 39, n. 4, p. 751, doi. 10.1215/03616878-2743027

By:

Hwang, Thomas J.;
Avorn, Jerry;
Kesselheim, Aaron S.

Publication type:

Article

Economics of alternative dosing strategies for pembrolizumab and nivolumab at a single academic cancer center.

Published in:

Cancer Medicine, 2020, v. 9, n. 6, p. 2106, doi. 10.1002/cam4.2888

By:

Hall, Evan;
Zhang, Jenny;
Kim, Eun Jeong;
Hwang, Grace;
Chu, Gilbert;
Bhatia, Shailender;
Reddy, Sunil

Publication type:

Article

The Ethics of Emergent Health Technologies: Implications of the 21st Century Cures Act for Nursing.

Published in:

Policy, Politics & Nursing Practice, 2020, v. 21, n. 4, p. 195, doi. 10.1177/1527154420947028

By:

Martin, Margaret

Publication type:

Article

Understanding Drug Development: A Primer on the Food and Drug Administration.

Published in:

Journal of the Pediatric Infectious Diseases Society, 2021, v. 10, n. 10, p. 977, doi. 10.1093/jpids/piab023

By:

Purandare, Amol V

Publication type:

Article

MARKETPLACE.

Published in:: Clinical Diabetes, 2019, v. 37, n. 2, p. 102
Publication type:: Article

Eversense Implantable CGM Receives Approval for Up to 90 Days' Usage.

Published in:: Clinical Diabetes, 2018, v. 36, n. 4, p. 278
Publication type:: Article

ITCA 650.

Published in:

Clinical Diabetes, 2018, v. 36, n. 3, p. 265, doi. 10.2337/cd18-0039

By:

Bertsch, Taylor;
McKeirnan, Kimberly

Publication type:

Article

Freestyle Libre Glucose Monitoring System.

Published in:

Clinical Diabetes, 2018, v. 36, n. 2, p. 203, doi. 10.2337/cd17-0130

By:

Blum, Alyson

Publication type:

Article

Diabetes Foot Ulcers: A Novel Dressing and Two New Therapeutic Devices.

Published in:: Clinical Diabetes, 2018, v. 36, n. 2, p. 94
Publication type:: Article

Procedural Outcome and One Year Follow up of Patients Undergoing Endovascular Stenting for Coarctation of Aorta: A Single Center Study.

Published in:

Journal of Cardiovascular & Thoracic Research, 2014, v. 6, n. 2, p. 117, doi. 10.5681/jcvtr.2014.025

By:

Ostovan, Mohammad Ali;
Kojuri, Javad;
Mokhtaryan, Maryam;
Razazi, Vida;
Zolghadrasli, Abdolali

Publication type:

Article

Standalone medical device software: The evolving regulatory framework.

Published in:

2015

By:

McCarthy, Avril D.;
Lawford, Patricia V.

Publication type:

journal article

EXOSKELETON TECHNOLOGY FOR SPINAL CORD INJURY.

Published in:

Journal of Nurse Life Care Planning, 2020, v. 20, n. 1, p. 7

By:

KREIMER, NELLIE

Publication type:

Article

Tek RMD now FDA-approved.

Published in:: Journal of Nurse Life Care Planning, 2015, v. 15, n. 3, p. 882
Publication type:: Article

Renal Denervation for Hypertension: The Current Landscape and Future Directions.

Published in:

Heart International, 2024, v. 18, n. 1, p. 5, doi. 10.17925/HI.2024.18.1.2

By:

Fulton, Brian;
Giri, Jay;
Rader, Florian;
Cohen, Debbie L.;
Taisei Kobayashi

Publication type:

Article

The Lost Decade: Clinical Trials Data Access After Seife v HHS.

Published in:

American Journal of Managed Care, 2021, v. 27, n. 2, p. e34, doi. 10.37765/ajmc.2021.88550

By:

Yang, Y. Tony;
Largent, Emily A.

Publication type:

Article

Unclear Labeling of Nicotine Products Poses Risks to Consumers.

Published in:

Nicotine & Tobacco Research, 2023, v. 25, n. 5, p. 1057, doi. 10.1093/ntr/ntac282

By:

Vogel, Erin A;
Tackett, Alayna P;
Barrington-Trimis, Jessica L

Publication type:

Article

The 510(k) Third Party Review Program: Promise and Potential.

Published in:

Journal of Medical Systems, 2023, v. 47, n. 1, p. 1, doi. 10.1007/s10916-023-01986-5

By:

Miller, Brian J.;
Blanks, William;
Yagi, Brian

Publication type:

Article

Evaluation of Over-the-Counter Portable Oxygen Concentrators Utilizing a Metabolic Simulator.

Published in:

Respiratory Care, 2023, v. 68, n. 4, p. 445, doi. 10.4187/respcare.10495

By:

Casaburi, Richard;
Hess, Michael;
Porszasz, Janos;
Clark, William;
Diesem, Ryan;
Tal-Singer, Ruth;
Ferguson, Carrie

Publication type:

Article