Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table.

The European Union (EU) Medical Device Regulation increased regulatory scrutiny to improve the safety and performance of new medical devices. An equally important goal is providing timely access to innovative devices to benefit patient care. The European Society of Cardiology strongly advocates for the evolution of the Medical Device Regulation system to facilitate priority access for innovative devices for unmet needs and orphan cardiovascular (CV) medical devices in EU countries.

CORE-MD clinical risk score for regulatory evaluation of artificial intelligence-based medical device software.

The European CORE-MD consortium (Coordinating Research and Evidence for Medical Devices) proposes a score for medical devices incorporating artificial intelligence or machine learning algorithms. Its domains are summarised as valid clinical association, technical performance, and clinical performance. High scores indicate that extensive clinical investigations should be undertaken before regulatory approval, whereas lower scores indicate devices for which less pre-market clinical evaluation may be balanced by more post-market evidence.

Large simple randomized controlled trials-from drugs to medical devices: lessons from recent experience.

Randomized controlled trials (RCTs) are the cornerstone of modern evidence-based medicine. They are considered essential to establish definitive evidence of efficacy and safety for new drugs, and whenever possible they should also be the preferred method for investigating new high-risk medical devices. Well-designed studies robustly inform clinical practice guidelines and decision-making, but administrative obstacles have made it increasingly difficult to conduct informative RCTs.

Safety notices and registry outlier data measure different aspects of safety and performance of total knee implants: a comparative study of safety notices and register outliers.

Background And Purpose:  Safety notices for medical devices such as total knee arthroplasty (TKA) implants may indicate problems in their design or performance that require corrective action to prevent patient harm. Safety notices are often published on national Ministries of Health or regulatory agencies websites. It is unknown whether problems triggering safety notices identify the same implants as those identified by registries as "outlier.

Standardized assessment of evidence supporting the adoption of mobile health solutions: A Clinical Consensus Statement of the ESC Regulatory Affairs Committee: Developed in collaboration with the European Heart Rhythm Association (EHRA), the Association of Cardiovascular Nursing & Allied Professions (ACNAP) of the ESC, the Heart Failure Association (HFA) of the ESC, the ESC Young Community, the ESC Working Group on e-Cardiology, the ESC Council for Cardiology Practice, the ESC Council of Cardio-Oncology, the ESC Council on Hypertension, the ESC Patient Forum, the ESC Digital Health Committee, and the European Association of Preventive Cardiology (EAPC).

Mobile health (mHealth) solutions have the potential to improve self-management and clinical care. For successful integration into routine clinical practice, healthcare professionals (HCPs) need accepted criteria helping the mHealth solutions' selection, while patients require transparency to trust their use. Information about their evidence, safety and security may be hard to obtain and consensus is lacking on the level of required evidence.

Orphan and paediatric medical devices in Europe: recommendations to support their availability for on-label and off-label clinical indications.

Introduction: The Medical Device Regulation (EU)745/2017, increased the regulatory requirements and thus the time and the cost associated with marketing medical devices. For a majority of medical device manufacturers, this has lead to reconsiderations of their product portfolio. The risk of important or essential devices being withdrawn is particularly relevant for pediatric patients and other rare disease patients where limited numbers of devices can be sold and hence the investment needed may not be recovered.

Clinical evidence for high-risk CE-marked medical devices for glucose management: A systematic review and meta-analysis.

Aims: To conduct a systematic review and meta-analysis, within the Coordinating Research and Evidence for Medical Devices (CORE-MD) project, evaluating CE-marked high-risk devices for glucose management.

Materials And Methods: We identified interventional and observational studies evaluating the efficacy and safety of eight automated insulin delivery (AID) systems, two implantable insulin pumps, and three implantable continuous glucose monitoring (CGM) devices. We meta-analysed randomized controlled trials (RCTs) comparing AID systems with other treatments.

Device innovation in cardiovascular medicine: a report from the European Society of Cardiology Cardiovascular Round Table.

Research performed in Europe has driven cardiovascular device innovation. This includes, but is not limited to, percutaneous coronary intervention, cardiac imaging, transcatheter heart valve implantation, and device therapy of cardiac arrhythmias and heart failure. An important part of future medical progress involves the evolution of medical technology and the ongoing development of artificial intelligence and machine learning.

Clinical investigations to evaluate high-risk orthopaedic devices: a systematic review of the peer-reviewed medical literature.

Purpose: The objective of this systematic review was to give an overview of clinical investigations regarding hip and knee arthroplasty implants published in peer-reviewed scientific medical journals before entry into force of the EU Medical Device Regulation in May 2021.

Methods: We systematically reviewed the medical literature for a random selection of hip and knee implants to identify all peer-reviewed clinical investigations published within 10 years before and up to 20 years after regulatory approval. We report study characteristics, methodologies, outcomes, measures to prevent bias, and timing of clinical investigations of 30 current implants.

Evidence from clinical trials on high-risk medical devices in children: a scoping review.

Background: Meeting increased regulatory requirements for clinical evaluation of medical devices marketed in Europe in accordance with the Medical Device Regulation (EU 2017/745) is challenging, particularly for high-risk devices used in children.

Methods: Within the CORE-MD project, we performed a scoping review on evidence from clinical trials investigating high-risk paediatric medical devices used in paediatric cardiology, diabetology, orthopaedics and surgery, in patients aged 0-21 years. We searched Medline and Embase from 1st January 2017 to 9th November 2022.

Quality and transparency of evidence for implantable cardiovascular medical devices assessed by the CORE-MD consortium.

Background And Aims: The European Union Medical Device Regulation 2017/745 challenges key stakeholders to follow transparent and rigorous approaches to the clinical evaluation of medical devices. The purpose of this study is a systematic evaluation of published clinical evidence underlying selected high-risk cardiovascular medical devices before and after market access in the European Union (CE-marking) between 2000 and 2021.

Methods: Pre-specified strategies were applied to identify published studies of prospective design evaluating 71 high-risk cardiovascular devices in seven different classes (bioresorbable coronary scaffolds, left atrial appendage occlusion devices, transcatheter aortic valve implantation systems, transcatheter mitral valve repair/replacement systems, surgical aortic and mitral heart valves, leadless pacemakers, subcutaneous implantable cardioverter-defibrillator).

Placing patient-reported outcomes at the centre of cardiovascular clinical practice: implications for quality of care and management.

Patient-reported outcomes (PROs) provide important insights into patients' own perspectives about their health and medical condition, and there is evidence that their use can lead to improvements in the quality of care and to better-informed clinical decisions. Their application in cardiovascular populations has grown over the past decades. This statement describes what PROs are, and it provides an inventory of disease-specific and domain-specific PROs that have been developed for cardiovascular populations.

Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review.

Background: The European Union Medical Device Regulation (MDR) requires manufacturers to undertake post-market clinical follow-up (PMCF) to assess the safety and performance of their devices following approval and Conformité Européenne (CE) marking. The quality and reliability of device registries for this Regulation have not been reported. As part of the Coordinating Research and Evidence for Medical Devices (CORE-MD) project, we identified and reviewed European cardiovascular and orthopaedic registries to assess their structures, methods, and suitability as data sources for regulatory purposes.

European expert recommendations on clinical investigation and evaluation of high-risk medical devices for children.

Several high-risk medical devices for children have become unavailable in the European Union (EU), since requirements and costs for device certification increased markedly due to the EU Medical Device Regulation. The EU-funded CORE-MD project held a workshop in January 2023 with experts from various child health specialties, representatives of European paediatric associations, a regulatory authority and the European Commission Directorate General Health and Food Safety. A virtual follow-up meeting took place in March 2023.

Artificial intelligence in medical device software and high-risk medical devices - a review of definitions, expert recommendations and regulatory initiatives.

Introduction: Artificial intelligence (AI) encompasses a wide range of algorithms with risks when used to support decisions about diagnosis or treatment, so professional and regulatory bodies are recommending how they should be managed.

Areas Covered: AI systems may qualify as standalone medical device software (MDSW) or be embedded within a medical device. Within the European Union (EU) AI software must undergo a conformity assessment procedure to be approved as a medical device.

Clinical evidence for high-risk medical devices used to manage diabetes: protocol for a systematic review and meta-analysis.

Introduction: Medical devices, including high-risk medical devices, have greatly contributed to recent improvements in the management of diabetes. However, the clinical evidence that is submitted for regulatory approval is not transparent, and thus a comprehensive summary of the evidence for high-risk devices approved for managing diabetes in Europe is lacking. In the framework of the Coordinating Research and Evidence for Medical Devices group, we will, therefore, perform a systematic review and meta-analysis, which will evaluate the efficacy, safety and usability of high-risk medical devices for the management of diabetes.

Validation of CORE-MD PMS Support Tool: A Novel Strategy for Aggregating Information from Notices of Failures to Support Medical Devices' Post-Market Surveillance.

Introduction: The EU Medical Device Regulation 2017/745 defines new rules for the certification and post-market surveillance of medical devices (MD), including an additional review by Expert Panels of clinical evaluation data for high-risk MD if reports and alerts suggest possibly associated increased risks. Within the EU-funded CORE-MD project, our aim was to develop a tool to support such process in which web-accessible safety notices (SN) are automatically retrieved and aggregated based on their specific MD categories and the European Medical Device Nomenclature (EMDN) classification by applying an Entity Resolution (ER) approach to enrich data integrating different sources. The performance of such approach was tested through a pilot study on the Italian data.

A concise history of echocardiography: timeline, pioneers, and landmark publications.

Echocardiography is less than 70 years old, and many major advances have occurred within living memory, but already some pioneering contributions may be overlooked. In order to consider what circumstances have been common to the most successful innovations, we have studied and here provide a timeline and summary of the most important developments in transthoracic and transoesophageal ultrasound imaging and Doppler techniques, as well as in intravascular ultrasound and imaging in paediatric cardiology. The entries are linked to a comprehensive list of first publications and to a collection of first-hand historical accounts published by early investigators.

History of Ultrasound in Medicine from its birth to date (2022), on occasion of the 50 Years Anniversary of EFSUMB. A publication of the European Federation of Societies for Ultrasound In Medicine and Biology (EFSUMB), designed to record the historical development of medical ultrasound.

The history of the European Federation of Societies in Ultrasound in Medicine and Biology (EFSUMB) is closely related to the general history of ultrasound. In the presented paper the physical background and history of technologies including A-mode, Time motion or M-mode, 2D Imaging (B-mode) are summarized. In addition, ultrasound tissue characterization, Doppler ultrasound, 3D and 4D ultrasound, intracavitary and endoscopic ultrasound, interventional ultrasound, ultrasonic therapy, contrast enhanced ultrasound (CEUS) and key developments in echocardiography are discussed.

Machine Learning for Clinical Decision-Making: Challenges and Opportunities in Cardiovascular Imaging.

The use of machine learning (ML) approaches to target clinical problems is called to revolutionize clinical decision-making in cardiology. The success of these tools is dependent on the understanding of the intrinsic processes being used during the conventional pathway by which clinicians make decisions. In a parallelism with this pathway, ML can have an impact at four levels: for data acquisition, predominantly by extracting standardized, high-quality information with the smallest possible learning curve; for feature extraction, by discharging healthcare practitioners from performing tedious measurements on raw data; for interpretation, by digesting complex, heterogeneous data in order to augment the understanding of the patient status; and for decision support, by leveraging the previous steps to predict clinical outcomes, response to treatment or to recommend a specific intervention.