Review

Accepted on 24 Dec 2024

Integrating environmental effects in the benefit-risk assessment of therapeutic products: a proposal and example for sustainable health and healthcare

in Substance-Based Medical Devices

Emiliano Giovagnoni
Luisa Mattoli
Andrea Cossu
Vitalia Murgia

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1519142

Original Research

Accepted on 23 Dec 2024

The safety and efficacy of neutral electrolyzed water solution for wound irrigation: Post-market clinical follow-up study

in Substance-Based Medical Devices

Veronika Valdova
Lenka Lapčíková
Vladimíra Štěpánová

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1402684

Original Research

Published on 17 Sep 2024

Demonstrating the principal mechanism of action of medical devices intended for vaginal use on reconstructed human vaginal epithelium: the case of two hyaluronic acid-containing devices

in Substance-Based Medical Devices

Marisa Meloni
Barbara De Servi
Francesco Carriero
Emmanuelle Simon O’Brien
Dounia Houamel
Philippe Deruelle
Vincent Castagné

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1445519

469 views

Opinion

Published on 03 Apr 2024

Regulation 2017/745 on medical devices, two major innovations: 1) the physiological action of devices consisting of natural materials such as vegetal matrices; 2) the chemical-physical-mechanical action of devices made of “substances”, which as such are artificial derivatives

in Substance-Based Medical Devices

Marcella Marletta

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1389406

832 views

Review

Published on 04 Aug 2023

Mucoadhesive polymers in substance-based medical devices: functional ingredients or what else?

in Substance-Based Medical Devices

Barbara Vigani
Silvia Rossi
Giuseppina Sandri
Maria Cristina Bonferoni
Carla M. Caramella

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2023.1227763

4,132 views
4 citations

Editorial

Published on 31 May 2023

Editorial: Substance-based medical devices for human health: a challenge of efficacy, safety, and sustainability

in Substance-Based Medical Devices

Alessandro Mugelli
Juan Tamargo

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2023.1222790

728 views

Methods

Published on 11 Apr 2023

Safety and efficacy of substance-based medical devices: Design of an in vitro barrier effect test

in Substance-Based Medical Devices

Rebecca Bassetto
Stefano Perin
Emanuele Amadio
Samuele Zanatta
Davide Nenzioni
Walter Bertin

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2023.1124873

1,345 views
1 citation

Review

Published on 24 Feb 2023

Gastrointestinal functional disorders can benefit from the use of medical devices made of substances

in Substance-Based Medical Devices

Vincenzo Savarino
Elisa Marabotto
Patrizia Zentilin
Manuele Furnari
Giorgia Bodini
Edoardo Giovanni Giannini
Edoardo Vincenzo Savarino

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2023.1119353

1,073 views

Policy and Practice Reviews

Published on 15 Dec 2022

Medicinal products, medical devices, or accessories of medical devices: How to qualify gases for spirometry?

in Substance-Based Medical Devices

Sara Manellari
Maria Grazia Leone
Antonella Casiraghi
Chiara Grazia Milena Gennari
Paola Minghetti

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.1089965

3,535 views
1 citation

Protocols

Published on 09 Dec 2022

A new platform for post-marketing surveillance and real-world evidence data collection for substance-based medical devices

in Substance-Based Medical Devices

Roberto Cioeta
Andrea Cossu
Emiliano Giovagnoni
Marta Rigoni
Paola Muti

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.992359

4,145 views
5 citations

Perspective

Published on 07 Dec 2022

European Union Regulation on clinical trials and Regulation on medical devices: A common soil for future development

in Substance-Based Medical Devices

Guido Rasi
Alessandro Mugelli

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.1071620

3,429 views

Correction

Published on 26 Oct 2022

Corrigendum: Substance-based medical devices made of natural substances: An opportunity for therapeutic innovation

in Substance-Based Medical Devices

Emiliano Giovagnoni

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.1054972

753 views

Original Research

Published on 10 Oct 2022

Effectiveness and tolerability of Poliprotect, a natural mucosal protective agent for gastroesophageal reflux disease and dyspepsia: Surveys from patients, physicians, and pharmacists

in Substance-Based Medical Devices

Roberto Cioeta
Paola Muti
Marta Rigoni
Luigi Morlando
Filippo Siragusa
Andrea Cossu
Emiliano Giovagnoni

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.969831

5,347 views
4 citations

Perspective

Published on 16 Sep 2022

New regulation on medical devices made of substances: Opportunities and challenges for pharmacological and toxicological research

in Substance-Based Medical Devices

Carmela Fimognari
Enrique Barrajón-Catalán
Cristina Luceri
Eleonora Turrini
Emanuel Raschi
Elisabetta Bigagli

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.1001614

1,628 views
4 citations

Perspective

Published on 02 Sep 2022

Substance-based medical devices made of natural substances: An opportunity for therapeutic innovation

in Substance-Based Medical Devices

Emiliano Giovagnoni

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.998114

3,529 views
4 citations

Perspective

Published on 04 Jul 2022

Medical Devices Made of Substances: A New Challenge

in Substance-Based Medical Devices

Maria Grazia Leone

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.952013

6,192 views
5 citations

Navigation group

Articles

Integrating environmental effects in the benefit-risk assessment of therapeutic products: a proposal and example for sustainable health and healthcare

The safety and efficacy of neutral electrolyzed water solution for wound irrigation: Post-market clinical follow-up study

Demonstrating the principal mechanism of action of medical devices intended for vaginal use on reconstructed human vaginal epithelium: the case of two hyaluronic acid-containing devices

Regulation 2017/745 on medical devices, two major innovations: 1) the physiological action of devices consisting of natural materials such as vegetal matrices; 2) the chemical-physical-mechanical action of devices made of “substances”, which as such are artificial derivatives

Mucoadhesive polymers in substance-based medical devices: functional ingredients or what else?

Editorial: Substance-based medical devices for human health: a challenge of efficacy, safety, and sustainability

Safety and efficacy of substance-based medical devices: Design of an in vitro barrier effect test

Gastrointestinal functional disorders can benefit from the use of medical devices made of substances

Medicinal products, medical devices, or accessories of medical devices: How to qualify gases for spirometry?

A new platform for post-marketing surveillance and real-world evidence data collection for substance-based medical devices

European Union Regulation on clinical trials and Regulation on medical devices: A common soil for future development

Corrigendum: Substance-based medical devices made of natural substances: An opportunity for therapeutic innovation

Effectiveness and tolerability of Poliprotect, a natural mucosal protective agent for gastroesophageal reflux disease and dyspepsia: Surveys from patients, physicians, and pharmacists

New regulation on medical devices made of substances: Opportunities and challenges for pharmacological and toxicological research

Substance-based medical devices made of natural substances: An opportunity for therapeutic innovation

Medical Devices Made of Substances: A New Challenge