IVDR regulation represents a major challenge for diagnostic microbiology laboratories. IVDR complicates a broad range of aspects and poses a risk given the high diversity of pathogens (including rare but highly virulent microbes) and the large variet...
The European Union In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) introduces companion diagnostics (CDx) as a new legal term. CDx are applied in combination with a medicinal product to identify patient subgroups most likely to be...
25 November 2022
Mitochondrial DNA (mtDNA) damage is closely associated with typical diseases of aging, such as Alzheimer’s or Parkinson’s disease, and other health conditions, such as infertility. This damage manifests in reduced mitochondrial copy numbe...
The virus discovered in 2019 in the city of Wuhan, China, which was later identified as SARS-CoV-2 and which spread to the level of a pandemic, put diagnostic methods to the test. Early in the pandemic, we developed a nested PCR assay for the detecti...
An integrative multi-modal metabolic phenotyping model was developed to assess the systemic plasma sequelae of SARS-CoV-2 (rRT-PCR positive) induced COVID-19 disease in patients with different respiratory severity levels. Plasma samples from 306 unva...
Vitamin D affects bone metabolism and calcium-phosphate metabolism. Its deficiency leads to bone mineralization disorders and is the cause of abnormal skeletal development from fetal life to the period of completed skeletal growth. In later periods o...
Background: Research to identify changes in driving behavior that occur with the onset of Pre-MCI and MCI is an emerging area with many gaps still to be addressed. These gaps include limited use of objective, continuous measurement of driver behavior...
Background: Medical laboratories may use examination procedures outside their originally intended scope, including a new specimen matrix, an extended measurement range, a different reagent–instrument combination, or a modified decision rule. Th...
This perspective provides an in-depth analysis of the role and tasks of Notified Bodies (NBs) under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). It explores the conformity assessment process and highlights typical is...
Intervertebral disc degeneration (IDD) is a leading cause of low back pain (LBP) and imposes a substantial social and economic burden. Current treatments mainly relieve symptoms but rarely halt or reverse disc degeneration, and key gaps remain in our...
There is a growing interest in the health benefits of functional foods. A benefit that has been long sought is the control of hypertension through dietary approaches. Hypertension has been implicated as a risk factor for cardiovascular disease and is...
This study examined the optimal sampling durations for in-vehicle data recorder (IVDR) data analysis, focusing on professional bus drivers. Vision-based technology (VBT) from Mobileye Inc. is an emerging technology for monitoring driver behavior and...
Point-of-care (POC) infectious disease diagnostics are reshaping global health by delivering rapid, decentralized, and clinically actionable results that link bedside testing to population-level surveillance. Valued at approximately USD 53 billion in...
The European Union medical device sector is analysed in several largely separate strands of the literature: regulatory studies of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR), innovation research on individual tec...
This article introduces a novel approach to digitize legislation using rule based-decision trees (RBDTs). As regulation is one of the major barriers to innovation, novel methods for helping stakeholders better understand, and conform to, legislation...
A third of large truck crashes are associated with driver-related factors, especially speeding. This study aimed to examine the impact of behavior-based safety (BBS) programs on speeding. Speeding data were examined from a trucking fleet that had inc...
Background: Clinical research has evolved into a multidisciplinary field integrating Medical Devices (MD), In Vitro Diagnostics (IVD), and Artificial Intelligence (AI), governed by a modernized European regulatory framework including the Clinical Tri...
Background/Objectives: The integration of artificial intelligence (AI) in medical devices has significant potential for transforming healthcare in the European Union (EU). However, AI medical devices are regulated under the Medical Devices Regulation...
5 September 2024
Background: Advancements in genomic technologies are rapidly evolving, with the potential to transform laboratory diagnostics by enabling high-throughput analysis of complex biological data, such as microbiome data. Large Language Models (LLMs) have...
Maternal folate receptor alpha autoantibodies (FRAA) have been associated with impaired placental folate transport, fetal cerebral folate deficiency (CFD) and neurodevelopmental risks including autism spectrum disorder (ASD); however, first-trimester...
Cerebrospinal fluid (CSF) oligoclonal band (OCB) analysis remains central to the diagnostic evaluation of neuroinflammatory diseases of the central nervous system (CNS), as it reflects intrathecal immunoglobulin synthesis. However, its reliance on lu...
The progressive integration of Whole Slide Imaging (WSI) technology and Artificial Intelligence (AI) architectures is driving a structural transformation in pathology and precision oncology. This structured critical review analyzes and systematizes t...
Background/Objectives: Artificial intelligence (AI) systems for detecting lymph node metastases in histopathological images achieve near-expert classification performance but remain opaque to clinicians, limiting their clinical adoption and regulator...