In Vitro Diagnostics Regulation News and Research

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How the new In-Vitro Diagnostics Regulations are affecting the life sciences landscape

In this interview, News-Medical talks to Laura Nea, Vice President of Quality and Regulatory Management at Tecan, about the upcoming changes to the regulations surrounding in-vitro diagnostics and how they might affect the life sciences landscape.

From Tecan 23 Nov 2021

Bruker’s molecular phenomics research tools enable new insights into ‘long COVID’ and post-acute metabolic abnormalities

A clinical research collaboration on COVID-19 pheno-conversion and subsequent pheno-reversion has discovered transient and persistent systemic changes of the molecular signatures in patient blood samples three months after the acute COVID-19 disease phase.

From Bruker BioSpin - NMR, EPR and Imaging 22 Jun 2021

BioEcho receives CE-IVD mark approval for SARS-CoV-2 RNA extraction kit

BioEcho Life Sciences announces that the company has recently received CE-mark approval for their EchoLUTION Viral RNA/DNA Swab Kit product line.

11 May 2021

NMR Metabolomics as Novel Screening Tool for New-borns (For Research Only)

In this interview, Oscar Millet, group leader of the Precision Medicine and Metabolism group of the CIC bioGUNE, talked to News Medical about his research into the use of nuclear magnetic resonance spectroscopy (NMR) metabolomic analysis as a clinical screening tool. His team has used NMR to screen urine samples form new-borns for congenital metabolic disorders.

From Bruker BioSpin - NMR, EPR and Imaging 20 Oct 2020

Bruker announces fully validated NMR module for metabolite quantification in urine (research use only)

Bruker has announced the release of the B.I.QUANT-UR™ 1.1 module, which complies with DIN-ISO criteria for the quantification of urine metabolites by NMR.

From Bruker BioSpin - NMR, EPR and Imaging 18 Feb 2020

GlobalData: Brexit deal with EU will change the landscape of medical device industry in UK

In the event of a free trade agreement with the EU, the UK will continue to be bound by current EU laws, thereby adhering to the new Medical Device Regulation. This will significantly change the landscape of the medical device industry, says GlobalData, a leading data and analytics company.

31 Jan 2020

Maetrics' new whitepaper highlights regulatory changes and challenges for combination product manufacturers

Maetrics, a leading international life sciences regulatory and compliance consultancy, has launched a new whitepaper on the adaptations and additions to the EU Medical Device Regulation pertaining to drug device combination products.

25 Jul 2019

Bruker announces novel phenomics solutions at Metabolomics 2019

At Metabolomics 2019, Bruker highlights innovative MS and NMR systems, and novel high-value solutions for molecular phenomics and clinical metabolomics.

From Bruker Life Sciences Mass Spectrometry 26 Jun 2019

NMR and metabolic phenotyping

In this interview, Dr Harmut Schafer introduces the work being done at the Phenome Center in Birmingham, on metabolic phenotyping using NMR.

From Bruker BioSpin - NMR, EPR and Imaging 31 Jan 2017

Bruker is to be key International Phenome Centre Network corporate partner for NMR Technologies and SOPs

The International Phenome Centre Network (IPCN), founded by Imperial College London and more than a dozen international partners in Australia, Canada, China, Japan, Singapore, Taiwan, the US, and the UK (www.phenomenetwork.org), was launched officially this week at the 2016 World Innovation Summit for Health (WISH) conference in Doha, Qatar. This global network is a critical link between leading research centers across the world and will support research into some of today’s most pressing global health challenges.

From Bruker 23 Jan 2017

Metabolomics and NMR

Bruker has been involved in the Phenome Center network since its beginning. Several years ago, the whole visionary concept of a global phenome network was actually born with Professor Jeremy Nicholson and Bruker BioSpin has been part of it since the early stages.

From Bruker BioSpin - NMR, EPR and Imaging 17 Jan 2017

Comprehensive NMR profiling module for detailed lipoprotein subclass analysis announced by Bruker (research use only)

At the 12th Annual Conference of the Metabolomics Society (www.metabolomics2016.org), Bruker announces a new, more comprehensive, more efficient and easy-to-use profiling module for detailed lipoprotein subclass analysis using Nuclear Magnetic Resonance (NMR).

From Bruker BioSpin - NMR, EPR and Imaging 1 Jul 2016

NMR-based metabolomics: an interview with Prof. Claudio Luchinat

Professor Claudio Luchinat, University of Florence and co-founder of the Magnetic Resonance Center (CERM), speaks to News-Medical about his research in NMR-based metabolomics.

From Bruker BioSpin - NMR, EPR and Imaging 9 Jun 2016

NMR Spectroscopy for In-Vitro Diagnostic Research

An interview with Dr. Manfred Spraul, discussing AVANCE, an advanced NMR spectrometer that is being applied to the fields of epidemiology and metabolomics.

From Bruker BioSpin - NMR, EPR and Imaging 2 Jul 2014

65 metabolites in urine simultaneously measured by clinical IEM-by-NMR screening study in Turkey

At the 12th International Congress of Inborn Errors of Metabolism (www.iciem2013.com), Bruker announces another milestone in the cost-effective use of NMR (nuclear magnetic resonance) spectroscopy screening as a clinical research tool for metabolic screening and small molecule in vitro diagnostics (IVD) research and validation.

4 Sep 2013

Bruker introduces AVANCE-IVDr platform for NMR clinical research and screening

Bruker today announces a standardized nuclear magnetic resonance (NMR) spectroscopy platform for its clinical and diagnostics partners that enables cost-effective, high-performance NMR clinical screening and IVD-by-NMR discovery, development and validation of novel NMR assays.

24 Jul 2013