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16 Results Found

  • Article
  • Open Access
3 Citations
4,322 Views
19 Pages

Raman Spectroscopy for Instant Bladder Tumor Diagnosis: System Development and In Vivo Proof-Of-Principle Study in Accordance with the European Medical Device Regulation (MDR2017/745)

  • Ines Latka,
  • Karin Mogensen,
  • Florian Knorr,
  • Cansu Kuzucu,
  • Florian Windirsch,
  • Dragan Sandic,
  • Jürgen Popp,
  • Gregers G. Hermann and
  • Iwan W. Schie

23 September 2024

This work reports on an in vivo Raman-based endoscopy system, invaScope, enabling Raman measurements of healthy and tumor bladder tissue during an endoscopic procedure in the operating theatre. The presented study outlines the progression from the in...

  • Article
  • Open Access
13 Citations
5,051 Views
17 Pages

Medical Device Regulation Efforts for mHealth Apps during the COVID-19 Pandemic—An Experience Report of Corona Check and Corona Health

  • Marc Holfelder,
  • Lena Mulansky,
  • Winfried Schlee,
  • Harald Baumeister,
  • Johannes Schobel,
  • Helmut Greger,
  • Andreas Hoff and
  • Rüdiger Pryss

16 June 2021

Within the healthcare environment, mobile health (mHealth) applications (apps) are becoming more and more important. The number of new mHealth apps has risen steadily in the last years. Especially the COVID-19 pandemic has led to an enormous amount o...

  • Article
  • Open Access
6 Citations
4,197 Views
8 Pages

Lack of Support in Medical Device Regulation within Academia

  • Rita Hendricusdottir,
  • Azad Hussain,
  • William Milnthorpe and
  • Jeroen HM Bergmann

New medical technologies can transform healthcare, and automation of processes is becoming increasingly ubiquitous within the patient care sector. Many innovative ideas arise from academia, but regulations need to be taken into account if they want t...

  • Review
  • Open Access
6 Citations
2,799 Views
14 Pages

Current Trends in the Development and Use of Personalized Implants: Engineering Concepts and Regulation Perspectives for the Contemporary Oral and Maxillofacial Surgeon

  • Alessandro Tel,
  • Alessandra Bordon,
  • Marco Sortino,
  • Giovanni Totis,
  • Lorenzo Fedrizzi,
  • Elisabetta Ocello,
  • Salvatore Sembronio and
  • Massimo Robiony

9 December 2021

The recently adopted Medical Device Regulation (MDR) has finally entered into force on 26 May 2021. As innovation and especially the advent of customized prostheses has deeply modified many surgical procedures in our discipline, it is imperative for...

  • Article
  • Open Access
20 Citations
9,736 Views
12 Pages

Medical Devices: Regulation, Risk Classification, and Open Innovation

  • Lukas Peter,
  • Ladislav Hajek,
  • Petra Maresova,
  • Martin Augustynek and
  • Marek Penhaker

In the Czech Republic, the medical device industry is an important sector with a strong tradition and has high added value and perspectives in demand under changing demographic and social structures. The aim of this article is to describe and analyze...

  • Article
  • Open Access
37 Citations
11,292 Views
18 Pages

New Regulations on Medical Devices in Europe: Are They an Opportunity for Growth?

  • Petra Maresova,
  • Ladislav Hajek,
  • Ondrej Krejcar,
  • Michael Storek and
  • Kamil Kuca

12 March 2020

Increasing demand for modern treatments and significant profit margins are strong incentives for investors and producers. However, the production and use of medical devices is subject to a number of laws, regulations, strict standards, and certificat...

  • Article
  • Open Access
36 Citations
4,336 Views
12 Pages

12 January 2023

Three-dimensional-printed medical devices are a separate group of medical devices necessary for the development of personalized medicine. The present article discusses a modern and specific group of medical devices and exoskeletons, which aims to pre...

  • Data Descriptor
  • Open Access
10 Citations
3,684 Views
8 Pages

10 November 2022

In Germany, the medical device industry constitutes a cornerstone of the health sector. In this study, we investigated the challenges and factors affecting the present-day performance of German SMEs concerned with medical devices. The research method...

  • Review
  • Open Access
16 Citations
5,415 Views
21 Pages

Expanding Quality by Design Principles to Support 3D Printed Medical Device Development Following the Renewed Regulatory Framework in Europe

  • Livia Adalbert,
  • S P Yamini Kanti,
  • Orsolya Jójárt-Laczkovich,
  • Hussein Akel and
  • Ildikó Csóka

16 November 2022

The vast scope of 3D printing has ignited the production of tailored medical device (MD) development and catalyzed a paradigm shift in the health-care industry, particularly following the COVID pandemic. This review aims to provide an update on the c...

  • Article
  • Open Access
2 Citations
3,960 Views
19 Pages

Guidance for Clinical Evaluation under the Medical Device Regulation through Automated Scoping Searches

  • Fu-Sung Kim-Benjamin Tang,
  • Mark Bukowski,
  • Thomas Schmitz-Rode and
  • Robert Farkas

28 June 2023

The Medical Device Regulation (MDR) in Europe aims to improve patient safety by increasing requirements, particularly for the clinical evaluation of medical devices. Before the clinical evaluation is initiated, a first literature review of existing c...

  • Review
  • Open Access
77 Citations
23,025 Views
16 Pages

18 December 2020

During the 20th century, metal alloys have assumed an important role as restorative materials. Among existing examples, cobalt–chromium (Co–Cr) alloys increasingly began to be used in medicine and especially in dentistry. Their success is...

  • Article
  • Open Access
7 Citations
3,332 Views
18 Pages

Personalization of the 3D-Printed Upper Limb Exoskeleton Design—Mechanical and IT Aspects

  • Dariusz Mikołajewski,
  • Izabela Rojek,
  • Piotr Kotlarz,
  • Janusz Dorożyński and
  • Jakub Kopowski

17 June 2023

The human hand is the most precise and versatile tool that nature has given man, and any deficits in this area affect the functional capabilities and quality of human life. Scientists, engineers and clinicians are constantly looking for solutions in...

  • Article
  • Open Access
8 Citations
2,871 Views
13 Pages

Suitability of R. pulmo Jellyfish-Collagen-Coated Well Plates for Cytocompatibility Analyses of Biomaterials

  • Yanru Ren,
  • Luo Liu,
  • Xin Xiong,
  • Rumen Krastev,
  • Ralf Smeets,
  • Denis Rimashevskiy,
  • Reinhard Schnettler,
  • Said Alkildani,
  • Steffen Emmert and
  • Ole Jung
  • + 1 author

3 February 2023

Cytocompatibility analyses of new implant materials or biomaterials are not only prescribed by the Medical Device Regulation (MDR), as defined in the DIN ISO Norm 10993-5 and -12, but are also increasingly replacing animal testing. In this context, j...

  • Review
  • Open Access
28 Citations
13,521 Views
30 Pages

Artificial Intelligence-Empowered Radiology—Current Status and Critical Review

  • Rafał Obuchowicz,
  • Julia Lasek,
  • Marek Wodziński,
  • Adam Piórkowski,
  • Michał Strzelecki and
  • Karolina Nurzynska

Humanity stands at a pivotal moment of technological revolution, with artificial intelligence (AI) reshaping fields traditionally reliant on human cognitive abilities. This transition, driven by advancements in artificial neural networks, has transfo...

  • Article
  • Open Access
17 Citations
4,722 Views
16 Pages

Protective Efficacy of Anti-Hyr1p Monoclonal Antibody against Systemic Candidiasis Due to Multi-Drug-Resistant Candida auris

  • Shakti Singh,
  • Ashley Barbarino,
  • Eman G. Youssef,
  • Declan Coleman,
  • Teclegiorgis Gebremariam and
  • Ashraf S. Ibrahim

12 January 2023

Candida auris is a multi-drug-resistant fungal pathogen that can survive outside the host and can easily spread and colonize the healthcare environment, medical devices, and human skin. C. auris causes serious life-threatening infections (up to 60% m...

  • Article
  • Open Access
6 Citations
2,677 Views
14 Pages

Endoscopic In Vivo Hyperspectral Imaging for Head and Neck Tumor Surgeries Using a Medically Approved CE-Certified Camera with Rapid Visualization During Surgery

  • Ayman Bali,
  • Thomas Bitter,
  • Marcela Mafra,
  • Jonas Ballmaier,
  • Mussab Kouka,
  • Gerlind Schneider,
  • Anna Mühlig,
  • Nadja Ziller,
  • Theresa Werner and
  • Ferdinand von Eggeling
  • + 2 authors

10 November 2024

Background: In vivo visualization of malignant tumors remains the main challenge during head and neck cancer surgery. This can result in inadequate tumor margin assessment and incomplete tumor resection, adversely affecting patient outcomes. Hyperspe...