Critical review of European health-economic guidelines for the health technology assessment of medical devices

M Blüher, SJ Saunders, V Mittard… - Frontiers in …, 2019 - frontiersin.org
Background: Health-technology assessment (HTA) is a recognized mechanism to determine
the relative benefits of innovative medical technologies. One aspect is their health-economic …

Health technology assessment of medical devices: current landscape, challenges, and a way forward

J Ming, Y He, Y Yang, M Hu, X Zhao, J Liu… - Cost Effectiveness and …, 2022 - Springer
Abstract Background Health Technology Assessment (HTA) has been widely recognized as
informing healthcare decision-making, and interest in HTA of medical devices has been …

Precision medicine and artificial intelligence: a pilot study on deep learning for hypoglycemic events detection based on ECG

M Porumb, S Stranges, A Pescapè, L Pecchia - Scientific reports, 2020 - nature.com
Tracking the fluctuations in blood glucose levels is important for healthy subjects and crucial
diabetic patients. Tight glucose monitoring reduces the risk of hypoglycemia, which can …

A framework for designing medical devices resilient to low-resource settings

D Piaggio, R Castaldo, M Cinelli, S Cinelli… - Globalization and …, 2021 - Springer
Abstract Background To date (April 2021), medical device (MD) design approaches have
failed to consider the contexts where MDs can be operationalised. Although most of the …

[HTML][HTML] Establishing a national HTA program for medical devices in Italy: Overhauling a fragmented system to ensure value and equal access to new medical …

R Tarricone, F Amatucci, P Armeni, H Banks, L Borsoi… - Health Policy, 2021 - Elsevier
Differing contexts have greatly influenced HTA development in various countries, with
considerable effort recently made by international HTA networks (eg, EUnetHTA) and the …

[HTML][HTML] Health technology assessment and biomedical engineering: global trends, gaps and opportunities

L Pecchia, N Pallikarakis, R Magjarevic… - Medical engineering & …, 2019 - Elsevier
The diffusion of medical devices is expanding at an astonishing rate. The increasing number
of novel patents per year suggests this growth will continue. In contrast to drugs, medical …

Shaking the usability tree: why usability is not a dead end, and a constructive way forward

S Borsci, S Federici, A Malizia… - Behaviour & information …, 2019 - Taylor & Francis
ABSTRACT A recent contribution to the ongoing debate concerning the concept of usability
and its measures proposed that usability reached a dead end–ie a construct unable to …

Performance-based risk-sharing arrangements for devices and procedures in cardiac electrophysiology: an innovative perspective

G Boriani, M Vitolo, E Svennberg, R Casado-Arroyo… - Europace, 2022 - academic.oup.com
There is an increasing pressure on demonstrating the value of medical interventions and
medical technologies resulting in the proposal of new approaches for implementation in the …

On the universality of medical device regulations: the case of Benin

A Maccaro, D Piaggio, S Leesurakarn, N Husen… - BMC health services …, 2022 - Springer
Background Regulatory frameworks surrounding medical devices (MDs) and medical
locations are of utter importance for safeguarding patients and users, and for granting a …

Effective and Efficient Delivery of Genome-Based Testing-What Conditions Are Necessary for Health System Readiness?

D Husereau, L Steuten, V Muthu, DM Thomas… - Healthcare, 2022 - mdpi.com
Health systems internationally must prepare for a future of genetic/genomic testing to inform
healthcare decision-making while creating research opportunities. High functioning testing …