Detalhe da pesquisa
1.
Quality and transparency of evidence for implantable cardiovascular medical devices assessed by the CORE-MD consortium.
Eur Heart J
; 45(3): 161-177, 2024 Jan 14.
Artigo
em Inglês
| MEDLINE | ID: mdl-37638967
2.
Evidence from clinical trials on high-risk medical devices in children: a scoping review.
Pediatr Res
; 95(3): 615-624, 2024 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-37758865
3.
A European regulatory pathway for Tidepool loop following clearance in the United States?
Diabet Med
; : e15246, 2023 Oct 24.
Artigo
em Inglês
| MEDLINE | ID: mdl-37873612
4.
European expert recommendations on clinical investigation and evaluation of high-risk medical devices for children.
Acta Paediatr
; 112(11): 2440-2448, 2023 Nov.
Artigo
em Inglês
| MEDLINE | ID: mdl-37485905
5.
Learning From Experience and Finding the Right Balance in the Governance of Artificial Intelligence and Digital Health Technologies.
J Med Internet Res
; 25: e43682, 2023 04 14.
Artigo
em Inglês
| MEDLINE | ID: mdl-37058329
6.
The IDEAL framework for surgical robotics: development, comparative evaluation and long-term monitoring.
Nat Med
; 30(1): 61-75, 2024 Jan.
Artigo
em Inglês
| MEDLINE | ID: mdl-38242979
7.
Can Apple and Google continue as health app gatekeepers as well as distributors and developers?
NPJ Digit Med
; 6(1): 8, 2023 Jan 31.
Artigo
em Inglês
| MEDLINE | ID: mdl-36721023
8.
Clinical investigations to evaluate high-risk orthopaedic devices: a systematic review of the peer-reviewed medical literature.
EFORT Open Rev
; 8(11): 781-791, 2023 Nov 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-37909694
9.
The European Medical Device Regulation-What Biomedical Engineers Need to Know.
IEEE J Transl Eng Health Med
; 10: 4800105, 2022.
Artigo
em Inglês
| MEDLINE | ID: mdl-36003070
10.
Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices).
EFORT Open Rev
; 6(10): 839-849, 2021 Oct.
Artigo
em Inglês
| MEDLINE | ID: mdl-34760284
11.
New medical device regulations: the regulator's view.
EFORT Open Rev
; 4(6): 351-356, 2019 Jun.
Artigo
em Inglês
| MEDLINE | ID: mdl-31312522
12.
Author Correction: The IDEAL framework for surgical robotics: development, comparative evaluation and long-term monitoring.
Nat Med
; 30(4): 1213, 2024 Apr.
Artigo
em Inglês
| MEDLINE | ID: mdl-38297095
13.
Large language model AI chatbots require approval as medical devices.
Nat Med
; 29(10): 2396-2398, 2023 Oct.
Artigo
em Inglês
| MEDLINE | ID: mdl-37391665