Detalhe da pesquisa
1.
Medicare's New Device-Coverage Pathway - Breakthrough or Breakdown?
N Engl J Med
; 384(12): e43, 2021 Mar 25.
Artigo
Inglês
| MEDLINE | ID: mdl-33691059
2.
Perioperative Complications in Posterior Pharyngeal Flap Surgery: Review of the National Surgical Quality Improvement Program Pediatric (NSQIP-PEDS) Database.
Cleft Palate Craniofac J
; 53(5): 562-7, 2016 09.
Artigo
Inglês
| MEDLINE | ID: mdl-26402723
3.
Aligning US Agency Policies for Cardiovascular Devices Through the Breakthrough Devices Program.
JAMA Cardiol
; 8(12): 1174-1181, 2023 12 01.
Artigo
Inglês
| MEDLINE | ID: mdl-37878306
4.
Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA.
Trials
; 22(1): 817, 2021 Nov 17.
Artigo
Inglês
| MEDLINE | ID: mdl-34789308
5.
US Food and Drug Administration Approval of Drugs Not Meeting Pivotal Trial Primary End Points, 2018-2021.
JAMA Intern Med
; 183(4): 376-380, 2023 04 01.
Artigo
Inglês
| MEDLINE | ID: mdl-36780148
6.
Approval of Drugs With Unmet Trial End Points-In Reply.
JAMA Intern Med
; 183(8): 889-890, 2023 08 01.
Artigo
Inglês
| MEDLINE | ID: mdl-37307009
7.
Market competition among manufacturers of novel high-risk therapeutic devices receiving FDA premarket approval between 2001 and 2018.
BMJ Surg Interv Health Technol
; 5(1): e000152, 2023.
Artigo
Inglês
| MEDLINE | ID: mdl-36793371
8.
Challenges and solutions to advancing health equity with medical devices.
Nat Biotechnol
; 41(5): 607-609, 2023 05.
Artigo
Inglês
| MEDLINE | ID: mdl-37037905
9.
Cardiovascular function and structure are preserved despite induced ablation of BMP1-related proteinases.
Cell Mol Bioeng
; 11(4): 255-266, 2018 Aug.
Artigo
Inglês
| MEDLINE | ID: mdl-30123369
10.
The pPSU Plasmids for Generating DNA Molecular Weight Markers.
Sci Rep
; 7(1): 2438, 2017 05 26.
Artigo
Inglês
| MEDLINE | ID: mdl-28550309
11.
Pulmonary arterial strain- and remodeling-induced stiffening are differentiated in a chronic model of pulmonary hypertension.
J Biomech
; 55: 92-98, 2017 04 11.
Artigo
Inglês
| MEDLINE | ID: mdl-28262286
12.
Assessment of FDA Approval for New High-risk Therapeutic Devices Not Meeting Pivotal Study Primary End Points, 2016-2020.
JAMA Intern Med
; 181(10): 1409-1412, 2021 10 01.
Artigo
Inglês
| MEDLINE | ID: mdl-34152383
13.
Clinical Evidence Supporting US Food and Drug Administration Clearance of Novel Therapeutic Devices via the De Novo Pathway Between 2011 and 2019.
JAMA Intern Med
; 180(12): 1701-1703, 2020 12 01.
Artigo
Inglês
| MEDLINE | ID: mdl-33044513
14.
Early experience with the FDA's Breakthrough Devices program.
Nat Biotechnol
; 38(8): 933-938, 2020 08.
Artigo
Inglês
| MEDLINE | ID: mdl-32704171