Devices In Europe Research Articles

Impact of Rule 11 on the European Medical Software Landscape: Analysis of EUDAMED and Further Databases Three Years After MDR Implementation.

Medicine is increasingly supported by software, with digital health technologies offering innovative ways to capture insights and drive therapies. Globally, medical device software must follow regulatory processes based on risk classification. The introduction of MDR represents a significant shift in risk-based classification for Medical Devices in Europe, including classification Rule 11 for software, which has caused significant discussions among European regulators. Three years after implementation, we conducted a systematic impact assessment of MDR classification Rule 11 for MDSW through a qualitative and quantitative analysis of over 2000 software entries from the European Medical Device database, complemented by data from other public databases such as the German DiGA directory and mHealthBELGIUM. Our results indicate that classification Rule 11 of the MDR results in a narrow bandwidth for class I software, whereas this used to be the most frequent classification for software under the MDD: while most of legacy software in EUDAMED falls in the lowest risk category as MDD Class I (53%), the situation reverses after the implementation of MDR with the most entries in Class IIa (55%). Analyzing the legacy MDD patient apps in Germany implies that three quarters will have to re-classify as MDR Class IIa at the end of the transition period in 2028. A comparison of the European and US regulatory landscapes, along with a systematic review of software features for Class I vs. Class IIa products, explains our findings and enables us to recommend a regulatory strategy for developing MDSW compliant with MDR Class I rules, ensuring fast access to the European market.

Minimum expectations for market authorization of continuous glucose monitoring devices in Europe-'eCGM' compliance status.

Minimum expectations for market authorization of continuous glucose monitoring devices in Europe-'eCGM' compliance status.

Initial Multicenter Experience With the New Castor Arch Branched Device in Europe: A Middle-term Results Study.

Published reports demonstrate that the use of Castor stent-graft is a promising treatment of aortic pathologies with the need to land in zone 2. However, there is a lack of publications on the medium-term results of Castor in the European population. This research evaluates the mid-term results of the Castor stent-graft in several Polish centers for the treatment of aortic pathologies and enriches the current knowledge of Castor stent-grafts. Twenty-one patients from 5 polish vascular surgery centers in subacute phase of type B aortic dissection (TBAD) with at least 1 classic risk factor of aneurysmatic degeneration, thoracic aortic aneurysms (TAAs) exceeding 5.5 cm, subacute phase of intramural hematomas (IMHs) and penetrating aortic ulcerations (PAUs) with at least 1 indication to endovascular treatment. Structure of the aortic arch and factors of aneurysmal degeneration for TBAD were highlighted. Early complications, long-term complications, and reinterventions after Castor device implantation are reported in the study. Twenty (95.24%) patients survived, of which a technical success involving implantation of the Castor device in the correct location with a patent branch for the left subclavian artery, and no endoleaks were noted in 19 (90.48%) patients. After the procedure, there were 2 (9.52%) cases of type I endoleak (in which technical success was not achieved) and 2 (9.52%) cases of bird beak. In addition, 1 case of access site hematoma, 1 case of pseudoaneurysm, and 1 case of access iliac artery rupture requiring implantation of a Viabahn device were observed. During the follow-up period (mean 14 months; range = 1-40 months), 1 patient required reintervention due to type I endoleak and 1 patient due to left subclavian artery (LSA) branch thrombosis. Two patients required subsequent branched endovascular aortic repair procedure due to unfavorable remodeling and fast aneurysm formation in visceral aorta, regardless of Castor results. The Castor device is an easy-to-use stent-graft with good medium-term results. It is an excellent option in cases requiring LSA revascularization during TEVAR. In this study, we investigate the medium-term results of the Castor stent graft in patients with type B aortic dissection, thoracic aortic aneurysm, intramural hematoma and penetrating aortic ulceration. The medium-term results of treatment with the Castor device are not yet well studied. Currently, there are only a small number of publications on the safety, complications and success of Castor device implantation.

Bioethanol burner operating parameters optimization: Effects of burner opening area modulation on heat output and flue gas composition

Bioethanol burners are significantly expanding devices in Europe, still considered preferably as the design element while its possible importance in the energy system of the household used to be neglected. The aim of this study was to determine the operating techno-environmental parameters as the heat output and the flue gas composition of the bioethanol fireplace with vortex flame. The measurement methodology was based on actual valid standard EN 16647 Fireplaces for Liquid Fuel. In general, three ethanol-based fuels were tested in combination with one bioethanol burner equipped with different regulation rings changing burner opening area. The average reached heat energy output ranged between 3.97 and 2.22 kW with maximal burner opening area (without the usage of regulation rings) for different fuels. By usage of the regulation rings, the heat energy output was reduced to 35 – 40 % of the nominal average heat output. Simultaneously the time of the burning of one fuel dose can be increased by regulation ring usage up to 195 % of the combustion time without the regulation ring. By placing the regulation rings on the burner bowl opening area, the flue gas composition was affected positively in terms of CO and negatively in terms of NOx.

Systematic Review and Meta-analysis of Short-term and Mid-term Outcomes After Use of t-Branch Off-the-shelf Multibranched Endograft for Elective and Urgent Treatment of Thoracoabdominal Aortic Aneurysms.

To conduct a meta-analysis to assess the safety and efficacy of t-Branch off-the-shelf multibranched endograft for the treatment of thoracoabdominal aortic aneurysm (TAAA). PubMed, Embase, and Web of Science. Online databases were searched from June 2012 to March 2023. The data were pooled together using a random-effects model of proportions. The outcomes overall included technical success, spinal cord ischemia, target vessel occlusion, type I or III endoleak, reintervention, early mortality (30-day), and mid-term outcomes. Subgroup meta-analyses and meta-regression were performed to explore variation among studies. A total of 15 studies containing 1238 patients were included in the meta-analysis. The overall study quality assessment was found to be moderate to good. The pooled technical success was 97.0% (95% confidence interval [CI]=95.5-98.6, I2=53.01%, 1185/1238 cases, 15 studies). Overall, early mortality was 7.3% (95% CI=4.4-10.1, I2=74.48%, 124/1238 cases, 15 studies). Early spinal cord ischemia was 13.4% (95% CI=9.6-17.2, I2=67.24%, 160/1238 cases, 15 studies), and early type I or III endoleak was 6.0% (95% CI=3.4-8.5, I2=53.71%, 68/1032 cases, 9 studies). Mid-term outcomes showed target vessel occlusion was 4% (95% CI=1.4-6.5, I2=65.18%, 28/528 cases, 10 studies, 5-21.2 months), type I or III endoleak was 4.7% (95% CI=2-7.5, I2=49.74%, 38/512 cases, 10 studies, 5-21.2 months), reintervention was 11.2% (95% CI=8.1-14.3, I2=31.06%, 85/650 cases, 10 studies, 5-21.2 months), and pooled mortality was 13.9% (95% CI=7.2-20.7, I2=76.32%, 84/550 cases, 11 studies, 5-21.2 months). Meta-regression found a significant linear association between higher technical success and earlier publication year (p=0.014) and studies with anatomic inclusion criteria (p=0.037). Urgent patients (p=0.021) and later publication year (p=0.048) were significantly associated with higher early mortality. The use of the off-the-shelf t-Branch multibranched endograft for elective or urgent endovascular TAAA repair is associated with high technical success rates and proved to be safe and effective at early and mid-term follow-up. However, the heterogeneity between the included studies is high, and prospective, randomized studies along with future larger studies with long-term follow-up are needed. The Zenith t-Branch (Cook Medical, Bloomington, Ind) was approved as a commercially available device in Europe in June 2012. Although a decade has past, the outcomes of t-Branch have rarely been synthesized at the global level. This meta-analysis included 15 studies containing 1238 patients. The meta-analyses included technical success, major adverse events, reintervention, early mortality, and mid-term outcomes. The outcome was very meaningful and representative for the use of t-Branch. It is helpful for endovascular surgeons to make decisions on the treatment of TAAA patients.

Gas plasmas technology: from biomolecule redox research to medical therapy.

Physical plasma is one consequence of gas ionization, i.e. its dissociation of electrons and ions. If operated in ambient air containing oxygen and nitrogen, its high reactivity produces various reactive oxygen and nitrogen species (RONS) simultaneously. Technology leap innovations in the early 2010s facilitated the generation of gas plasmas aimed at clinics and operated at body temperature, enabling their potential use in medicine. In parallel, their high potency as antimicrobial agents was systematically discovered. In combination with first successful clinical trials, this led in 2013 to the clinical approval of first medical gas plasma devices in Europe for promoting the healing of chronic and infected wounds and ulcers in dermatology. While since then, thousands of patients have benefited from medical gas plasma therapy, only the appreciation of the critical role of gas plasma-derived RONS led to unraveling first fragments of the mechanistic basics of gas plasma-mediated biomedical effects. However, drawing the complete picture of effectors and effects is still challenging. This is because gas plasma-produced RONS not only show a great variety of dozens of types but also each of them having distinct spatio-temporal concentration profiles due to their specific half-lives and reactivity with other types of RONS as well as different types of (bio) molecules they can react with. However, this makes gas plasmas fascinating and highly versatile tools for biomolecular redox research, especially considering that the technical capacity of increasing and decreasing individual RONS types holds excellent potential for tailoring gas plasmas toward specific applications and disease therapies.

Regulating Artificial Intelligence and Machine Learning-Enabled Medical Devices in Europe and the United Kingdom

Recent achievements in respect of Artificial Intelligence (AI) open up opportunities for new tools to assist medical diagnosis and care delivery. However, the typical process for the development of AI is through repeated cycles of learning and implementation, something that poses challenges to our existing system of regulating medical devices. Product developers face tensions between the benefits of continuous improvement/deployment of algorithms and keeping products unchanged. The latter more easily facilitates collecting evidence for safety assurance processes but sacrifices optimisation of performance and adaptation to user needs gained through learning-implementation cycles. The challenge is how to balance potential benefits with the need to assure their safety. Governance and assurance processes are needed that can accommodate real-time or near-real-time machine learning. Such an approach is of great importance in healthcare and other fields of application. AI has stimulated an intense process of learning as this new technology embeds in application contexts. The process is not only about the application of AI in the real world but also about the institutional arrangements for its safe and dependable deployment, including regulatory experimentation involving new market pathways, monitoring and surveillance, and sandbox schemes. We review the key themes, challenges and potential solutions raised at two stakeholder workshops and highlight recent attempts to adapt the laws for AI-enabled medical devices (AIeMD) with a special focus on the regulatory proposals in the UK and internationally. The UK regulatory trajectory shows signs of alignment with the US thinking, and yet the European Union model is still the most closely aligned framework.

Medical Gas Plasma Technology Combines with Antimelanoma Therapies and Promotes Immune-Checkpoint Therapy Responses.

Strategies to improve activity and selectivity are major goals in oncological drug development. Medical gas plasma therapy has been subject to intense research in dermatooncology recently. Based on partial gas ionization, this approach is exceptional in generating a variety of reactive oxygen species simultaneously that can be applied locally at the tumor side. It is hypothesized that combined gas plasma treatment can potentiate drug responses in the treatment of melanoma. Using a plasma jet approved as medical device in Europe, a systematic screening of 46 mitochondria-targeted drugs identifies five agents synergizing in vitro and in vivo. Increased intratumoral leucocyte infiltration points to immunomodulatory aspects of the treatment, motivating to investigate responses to immune checkpoint blockade in combination with plasma. Tumor growth is monitored based on bioluminescent imaging, and single-cell suspensions are retrieved from each tumor to characterize tumor-infiltrating leucocytes using multicolor flow cytometry. Gene expression profiling is done using a validated NanoString panel targeting 770 genes specifically designed for immuno-oncological research. Cell type abundancies are characterized from bulk RNA samples using the CIBERSORT computational framework. Collectively, the results indicate that local application of medical gas plasma technology synergizes with mitochondria-targeted drugs and anti-PD1 checkpoint therapy in treating melanoma.

Gaps in the evidence underpinning high-risk medical devices in Europe at market entry, and potential solutions

AimTo determine the level of evidence for innovative high-risk medical devices at market entry.MethodsWe reviewed all Belgian healthcare payer (RIZIV-INAMI) assessor reports on novel implants or invasive medical devices (n = 18, Class IIb-III) available between 2018 to mid-2019 on applications submitted for inclusion on their reimbursement list. We also conducted a review of the literature on evidence gaps and an analysis of relevant legal and ethical frameworks within the European context.FindingsConformity assessment of medical devices is based on performance, safety, and an acceptable risk-benefit balance. Information submitted for obtaining CE marking is confidential and legally protected, limiting access to clinical evidence. Seven out of the 18 RIZIV-INAMI assessor reports (39%) included a randomized controlled trial (RCT) using the novel device, whilst 2 applications (11%) referred to an RCT that used a different device. The population included was inappropriate or unclear for 3 devices (17%). Only half of the applications presented evidence on quality of life or functioning and 2 (11%) presented overall survival data. Four applications (22%) included no data beyond twelve months. The findings from the literature demonstrated similar problems with the study design and the clinical evidence.Discussion and conclusionsCE marking does not indicate that a device is effective, only that it complies with the law. The lack of transparency hampers evidence-based decision making. Despite greater emphasis on clinical benefit for the patient, the provisions of the European Medical Device Regulation (MDR) are not yet fully aligned with international ethical standards for clinical research. The MDR fails to address key issues, such as the lack of access to data submitted for CE marking and a failure to require evidence of clinical effectiveness. Indeed, a first report shows no improvement in the clinical evidence for implantable devices generated under the MDR. Thus, patients may continue to be exposed to ineffective or unsafe novel devices. The Health Technology Assessment Regulation plans for Joint Scientific Consultations for specific high-risk devices before companies begin their pivotal clinical investigations. The demanded comparative evidence should facilitate payer decisions. Nevertheless, there is also a need for legislation requiring comparative RCTs assessing patient-relevant outcomes for high-risk devices to ensure implementation, including development and implementation of common specifications for study designs.

A European update on transcatheter aortic valve implantation (TAVI) in the COVID era.

Minimally invasive approaches for aortic valve replacement are now at the forefront of pathological aortic valve treatment. New trials show comparability of these devices to existing therapies, not only in high-risk surgical cohorts but also in low-risk and intermediate-risk cohorts. This review provides vital clinical and anatomical background to aortic valvular disease treatment guidelines, while also providing an update on transcatheter aortic valve implantation (TAVI) devices in Europe, their interventional trials and associated complications.

Pushing the boundaries of evaluation, diffusion, and use of medical devices in Europe: Insights from the COMED project.

The field of medical devices has attracted considerable interest from scholarly research in health economics in recent years. Medical devices are indispensable tools for quality health care delivery, but their assessment and appropriate use pose significant challenges to healthcare systems. More research is needed to overcome existing gaps associated with evaluation of digital technologies, address challenges in the use of real-world data in generating evidence for decision-making and to uncover drivers of variation in access to medical devices across countries. Furthermore, the translation of the results and recommendations stemming from research projects into health technology assessment practices needs to be strengthened. The European Union (EU) project COMED aimed to address these gaps by improving existing research and developing new research streams on the methods for evaluation and diffusion of medical devices. The project also intended to provide directly applicable policy advice and tools to inform decision-making, with the aim of impacting public health in the EU. This Health Economics Supplement, together with references of other published outputs of the project, is intended to be the main source for researchers and policy makers seeking information on the COMED project.

Comparison of the regulatory requirements for custom-made medical devices using 3D printing in Europe, the United States, and Australia.

Additive manufacturing (AM) has continuously grown in recent decades. Enhanced quality, further development of technology, and fall in prices make AM applicable and capable for various industrial applications, also for the manufacture of medical devices. 3D printing offers the possibility for an unprecedented adaptation to the anatomy of each patient, generating medical devices on a case-by-case basis. In many jurisdictions, custom-made devices qualify for anexemption to pre-market approval standards. This regulation is called into question by new technologies, like AM. Therefore, this article compares the current regulatory requirements for custom-made devices in Europe, the United States, and Australia and discusses the impact on 3D printed devices. It concludes that not alljurisdictions have yet adjusted their regulatory framework for custom-made devices to technological advances. Remaining uncertainties must be eliminated in order to help manufacturers comply with the regulatory requirements, emphasizing key aspects of AM.

A cross-sectional study on the anatomic feasibility of iliac side branch grafts in a real-world setting

ObjectiveThe aim of this cross-sectional, single-center study was to analyze the feasibility of different commercially available iliac branch devices in Europe in a cohort of patients with aorto-iliac aneurysms. MethodsAll patients with aorto-iliac or iliac aneurysms that required iliac aneurysm repair, between 2017 and 2021, were included. Morphologic data was analyzed using computed tomography angiograms. The main outcome was the feasibility of each endoprosthesis (Cook ZBIS, Gore Iliac Branch Endoprosthesis [IBE], and JOTEC E-Iliac) according to the manufacturer’s instructions for use. Secondary outcomes were feasibility in all three devices, in any device, and with adjunctive procedures (liberal criteria). Additionally, a comparative analysis of all three grafts was performed to analyze differences in feasibility. ResultsOverall, 119 iliac aneurysms in 101 patients were included. The mean age was 71 ± 11 years, and 91.6% were male. Feasibility was 52.9% for Cook ZBIS, 33.6% for Gore IBE, and 26.9% for the JOTEC E-Iliac device. A total of 65.5% of patients were feasible with at least one device, whereas only 10.1% complied with all three devices. The main reasons for lack of feasibility were a short common iliac artery length (Cook ZBIS), a narrow common iliac artery diameter (Gore IBE), and a >50° angulation between the external and internal iliac arteries (JOTEC E-Iliac). There was a significant difference between the feasibility of the three devices (P < .001). Cook ZBIS was the graft with the higher feasibility, with 3.3 and 4.4 higher odds when compared with Gore IBE and JOTEC E-Iliac devices, respectively. There was no significant difference between the Gore IBE and the JOTEC E-Iliac. By using liberal criteria, the overall feasibility increased to 95.8%. ConclusionsWe found that only 65.5% of patients were feasible with one of the available devices according to the manufacturer’s instructions for use. The Cook ZBIS was the device with the overall highest feasibility. Extending the use of these devices with adjunctive measures and a more liberal approach increased feasibility to 95.8%.

Coverage with evidence development for medical devices in Europe: Can practice meet theory?

Health economists have written extensively on the design and implementation of coverage with evidence development (CED) schemes and have proposed theoretical frameworks based on cost‐effectiveness modeling and value of information analysis. CED may aid decision‐makers when there is uncertainty about the (cost‐)effectiveness of a new health technology at the time of reimbursement. Medical devices are potential candidates for CED schemes, as regulatory regimes do not usually require the same level of efficacy and safety data normally needed for pharmaceuticals. The purpose of this research is to assess whether the actual practice of CED for medical devices in Europe meets the theoretical principles proposed by health economists and whether theory and practice can be more closely aligned. Based on decision‐makers' perceptions of the challenges associated with CED schemes, plus examples from the schemes themselves, we discuss a series of proposals for assessing the desirability of schemes, their design, implementation, and evaluation. These proposals, while reflecting the practical challenges with developing CED programs, embody many of the principles suggested by economists and should support decision‐makers in dealing with uncertainty about the real‐world performance of devices.

Regulatory framework for 3D printed custom-made devices in Europe

Additive manufacturing (AM) has been growing continuously over the past 20 years, enabling unprecedented tailoring to the anatomy of each patient. In Europe, custom-made devices qualify for an exemption and pass a simplified approval process. New technologies, like AM, provoke questions about the adequacy of the current regulatory framework for custom-made devices. This article addresses the regulatory requirements for such devices in Europe and discusses the implications for AM. It concludes that the legal framework for custom-made devices entails uncertainties which need to be resolved to guide manufacturers through the regulatory requirements, highlighting the specific areas of focus for AM.

Expanding long-acting contraceptive options: a prospective cohort study of the hormonal intrauterine device, copper intrauterine device, and implants in Nigeria and Zambia

SummaryBackground30 years after the introduction of the levonorgestrel-releasing intrauterine device in Europe, several sub-Saharan African countries are seeking to broaden access to this contraceptive method. In this study, we aimed to assess 12-month continuation of the hormonal intrauterine device, copper intrauterine device, and implants, as well as to assess women's experiences and satisfaction using these methods in the private sector in Nigeria and the public sector in Zambia.MethodsWe did a prospective cohort study of long-acting reversible contraceptive users across 40 private sector clinics in Nigeria and 21 public sector clinics in Zambia. Eligible women were aged 18–49 years in Nigeria and 16–49 years in Zambia, had chosen to receive the hormonal intrauterine device, copper intrauterine device, or implant (either a 5-year levonorgestrel-releasing subdermal implant or a 3-year etonogestrel-releasing subdermal implant), and, in Nigeria only, had access to a telephone. Women were interviewed within 100 days of receiving their contraceptive method either via telephone in Nigeria or in person in Zambia, with follow-up surveys at 6 months and 12 months. The primary outcomes were method-specific, 12-month continuation rates—ie, continuation rates of the hormonal intrauterine device, copper intrauterine device, and implant across Nigeria and Zambia. We used Kaplan-Meier methods to estimate the cumulative probabilities of method-specific continuation and a log-rank test to compare contraceptive methods. We analysed self-reported satisfaction and experiences as a secondary outcome.FindingsBetween June 25 and Nov 22, 2018, we enrolled a total of 1542 women (n=860 in Nigeria and n=682 in Zambia) receiving a long-acting reversible contraceptive. In total, 835 women (266 [32%] hormonal intrauterine device users, 274 [33%] copper intrauterine device users, and 295 [35%] implant users) in Nigeria and 367 (140 [38%] hormonal intrauterine device users, 149 [40%] copper intrauterine device users, and 78 [21%] implant users) in Zambia were included in the study analysis. The 12-month cumulative continuation rates were 86·8% (95% CI 82·1–90·4) for the hormonal intrauterine device, 86·9% (82·1–90·4) for the copper intrauterine device, and 85·0% (80·2–88·7) for implants in Nigeria. In Zambia, the 12-month cumulative continuation rates were 94·7% (89·2–97·4) for the hormonal intrauterine device, 89·1% (82·3–93·4) for the copper intrauterine device, and 83·1% (72·2–90·1) for implants. At least 71% of respondents across the timepoints were very satisfied with their method, and at least 55 (79%) of 70 reported having recommended their contraceptive method to someone else. Across the methods, the most commonly self-reported positive aspect of long-acting reversible contraceptive use at 12 months was effectiveness in Nigeria (range 93–94%) and long-lasting duration in Zambia (48–60%). Between 124 (50%) of 248 and 136 (59%) of 230 Nigerian participants and 26 (42%) of 62 and 66 (57%) of 117 Zambian participants reported nothing negative about their contraceptive method.InterpretationOur study showed high continuation rates and satisfaction across long-acting reversible contraceptives, including the hormonal intrauterine device, a method that has been largely underused in sub-Saharan Africa. This finding supports the inclusion of the hormonal intrauterine device as a valuable addition to the mix of contraceptive methods in Nigeria and Zambia.FundingBill & Melinda Gates Foundation.

Improvement of Reimbursement Policies for Medical Products Through Health Technology Assessment

Reimbursement policies for medical devices in EU and health technology assessment (HTA) are at the heart of this article. Their development is the result of coordination of many institutions - the European Commission, the European Parliament, the government, agencies and their importance is key. The financial instruments in the reimbursement policies for medical devices in the EU are becoming more and more avant-garde, with the key importance of those from donations or crowdfunding, fundraising for patient organizations and others. The authors emphasize the role of public administration in the formation of effective reimbursement policies for medical devices in line with trends and good practices in the field of medical devices and active participation in the processes, together with European institutions and programs. The authors of the article discuss alternative and innovative approaches, budget impact assessment and reimbursement policies for medical devices in Europe and the EU based on HTA. The authors focus their research on the European experience, the synchronization with European regulations, the harmo-nization of management methods and the role of HTA in the field of management of public funds by institutions and public organizations in Bulgaria. The authors of the publication examine the experience of international institutes in the field of HTA-experience of Great Britain, Germany, France, given the benchmark they have and the need to educate health professionals, administrators, companies in Bulgaria.

Coverage with evidence development schemes for medical devices in Europe: characteristics and challenges

ObjectivesMedical devices are potentially good candidates for coverage with evidence development (CED) schemes, as clinical data at market entry are often sparse and (cost-)effectiveness depends on real-world use. The objective of this research was to explore the diffusion of CED schemes for devices in Europe, and the factors that favour or hamper their utilization.MethodsWe conducted structured interviews with 25 decision-makers from 22 European countries to explore the characteristics of existing CED programmes for devices, and how decision makers perceived 13 pre-identified challenges associated with initiating and operating CED schemes for devices. We also collected data on individual schemes that were either initiated or still ongoing in the last 5 years.ResultsWe identified seven countries with CED programmes for devices and 78 ongoing schemes. The characteristics of CED programmes varied across countries, including eligibility criteria, roles and responsibilities of stakeholders, funding arrangements, and type of decisions being contemplated at the outset of each scheme. We observed a high variability in how decision makers perceived CED-related challenges possibly reflecting country-specific arrangements and different experiences with CED. One general finding across all countries was that relatively little attention was paid to the evaluation of schemes, both during and at their completion.ConclusionsCED programmes for devices with different characteristics exist in Europe. Decision-makers’ perceptions differ on the challenges associated with these schemes. More exchange of knowledge and experience will help decision makers anticipate the likely challenges in CED schemes for devices, and to learn from good practices existing elsewhere.

Diagnostics of diseases of the optic nerve head in times of artificial intelligence and big data

HintergrundDer Einsatz von künstlicher Intelligenz (KI) ist unter anderem in der automatischen Bildsegmentierung, -analyse und Klassifikation interessant und bereits für verschiedene Bereiche der Augenheilkunde beschrieben.FragestellungDiese Arbeit soll einen Überblick über aktuelle Ansätze und Fortschritte bei der Anwendung von Big Data und KI bei verschiedenen Erkrankungen des Sehnervenkopfes geben.Material und MethodeEs wurde eine PubMed-Recherche durchgeführt. Gesucht wurde nach Studien, die klinische Fragestellungen mithilfe von Big-Data-Ansätzen beantworteten oder klassische Methoden des maschinellen Lernens bei der Analyse von multimodaler Bildgebung des Sehnervenkopfes verwendeten.ErgebnisseBig Data kann bei Volkskrankheiten wie dem Glaukom helfen, klinische Fragestellungen zu beantworten. KI findet sowohl bei der Segmentierung von multimodaler Bildgebung des Sehnervenkopfes als auch bei der Klassifikation von Erkrankungen wie dem Glaukom oder der Stauungspapille auf diesen Bilddaten Anwendung.SchlussfolgerungMithilfe von Big Data und KI können Zusammenhänge besser erkannt und die Diagnostik und Verlaufsbeurteilung von Erkrankungen des Sehnervenkopfes erleichtert oder automatisiert werden. Eine Voraussetzung für die klinische Anwendung ist in Europa die CE-Kennzeichnung als ein Medizinprodukt und in den USA die Zulassung durch die Food and Drug Administration.

Do existing real-world data sources generate suitable evidence for the HTA of medical devices in Europe? Mapping and critical appraisal.

Technological and computational advancements offer new tools for the collection and analysis of real-world data (RWD). Considering the substantial effort and resources devoted to collecting RWD, a greater return would be achieved if real-world evidence (RWE) was effectively used to support Health Technology Assessment (HTA) and decision making on medical technologies. A useful question is: To what extent are RWD suitable for generating RWE? We mapped existing RWD sources in Europe for three case studies: hip and knee arthroplasty, transcatheter aortic valve implantation (TAVI) and mitral valve repair (TMVR), and robotic surgery procedures. We provided a comprehensive assessment of their content and appropriateness for conducting the HTA of medical devices. The identification of RWD sources was performed combining a systematic search on PubMed with gray literature scoping, covering fifteen European countries. We identified seventy-one RWD sources on arthroplasties; ninety-five on TAVI and TMVR; and seventy-seven on robotic procedures. The number, content, and integrity of the sources varied dramatically across countries. Most sources included at least one health outcome (97.5%), with mortality and rehospitalization/reoperation the most common; 80% of sources included resource outcomes, with length of stay the most common, and comparators were available in almost 70% of sources. RWD sources bear the potential for the HTA of medical devices. The main challenges are data accessibility, a lack of standardization of health and economic outcomes, and inadequate comparators. These findings are crucial to enabling the incorporation of RWD into decision making and represent a readily available tool for getting acquainted with existing information sources.