In Vitro Diagnostics News and Research

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Another study to show the performance of the Quo-Test® HbA1c analyzer by EKF meets criteria

EKF, announces in published paper Quo-Test POC hemoglobin A1c analyzer has been confirmed to meet IFCC and Laboratory Medicine criteria.

From EKF Diagnostics 16 Feb 2017

FDA grants permission to market new Seeker System for screening rare metabolic disorders in newborns

The U.S. Food and Drug Administration today permitted marketing of the Seeker System for the screening of four, rare Lysosomal Storage Disorders (LSDs) in newborns.

3 Feb 2017

Illumina debuts new software to optimize data analysis for noninvasive prenatal testing

Illumina, Inc. today announced that it has declared conformity with the requirements of the IVD Directive and has applied the CE mark to an expanded VeriSeq NIPT Analysis Software for clinical laboratories in the European Union (EU).

From Illumina, Inc. 3 Feb 2017

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

Mobidiag announces CE-IVD marking of Amplidiag Easy that automates workflow from sample to results

Mobidiag Ltd, a Finnish molecular diagnostics company, today announced the CE-IVD marking of Amplidiag® Easy, a proprietary system allowing nucleic acid extraction and PCR setup directly from stool samples.

25 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

FDA expands approved use of G5 Mobile Continuous Glucose Monitoring System

The U.S. Food and Drug Administration today expanded the approved use of Dexcom's G5 Mobile Continuous Glucose Monitoring System to allow for replacement of fingerstick blood glucose (sugar) testing for diabetes treatment decisions in people 2 years of age and older with diabetes.

21 Dec 2016

OGT introduces three new Cytocell Aquarius FISH probes

Oxford Gene Technology (OGT), The Molecular Genetics Company,has expanded its range of Cytocell Aquarius®fluorescence in situ hybridisation (FISH) probes for pathology.

16 Dec 2016

biosurfit announces CE Marking for new HbA1c test

Today, biosurfit SA, the in vitro point-of-care (PoC) diagnostics company, announces CE Marking (Conformité Européenne) for its HbA1c (Haemoglobin A1c) test, the third in a series of tests available on its spinit point-of-care instrument.

1 Dec 2016

Six pioneering French companies to exhibit in innovation zone at Medica 2016

In a global market worth almost €200 billion (around £173 billion) a year, the medical devices and in vitro diagnostics sector is particularly innovative in France. Across the Channel, the sector is comprised of over a thousand companies, employing almost 65,000 people with expertise encompassing medicine, mechanics, material physics and digital technologies.

10 Nov 2016

BBI Solutions to showcase Morffi signal enhancement technology at MEDICA 2016

BBI Solutions will be showcasing its Morffi signal enhancement technology on Stand F26 in Hall 1 at MEDICA 2016.

10 Nov 2016

Tecan launches new Cavro Omni Flex for OEM applications

Tecan is making it quicker and easier than ever before for manufacturers to develop instruments for advanced liquid handling applications.

From Tecan 9 Nov 2016

Procorre urges Medical Devices industry to prepare for new ISO13485:2016 International Standard and MDD & IVD ‘Recast’

Professional services consultancy, Procorre is urging the Medical Devices industry to take action ahead of the new ISO13485:2016 International Standard and MDD & IVD ‘Recast’ which become mandatory in less than three years’ time.

4 Nov 2016

Illumina donates more than 95,000 human genetic variants to ClinVar database

Illumina, Inc. announced that it has contributed over 95,000 human genetic variants to ClinVar, a public database hosted by the National Center for Biotechnology Information (NCBI).

From Illumina, Inc. 1 Nov 2016

FDA approves new fully automated blood analyzer for high-volume transfusion labs

Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, today announced that ORTHO VISION Max, a fully automated blood analyzer for high-volume transfusion medicine laboratories, received 510(k) clearance, signifying its conformity with U.S. Food and Drug Administration regulation.

24 Oct 2016

Future of diagnostics to be unveiled by ITL at Medica 2016

Leading medical device design and manufacturing company ITL is unveiling something exciting at MEDICA tradeshow in Düsseldorf, Germany this November.

From Vitl Life Science Solutions 20 Oct 2016

New bio-photonic device aims to take drug hypersensitivity detection into new era

Over 2.5 million people in Europe and more than 5.4 million Americans suffer from hypersensitivity to Beta Lactam Antibiotics (BLCs), the most commonly prescribed drugs that contain the penicillin family, with up to 10 percent of people reporting an allergy.

20 Oct 2016

OGT announces expansion of Cytocell Aquarius Haematology FISH probe range

Oxford Gene Technology, The Molecular Genetics Company, has today announced a significant expansion of its existing catalogue of Cytocell Aquarius Haematology probes for fluorescence in situ hybridisation (FISH) — underlining the company's position as the one-stop-shop for high-quality FISH probes.

13 Oct 2016

FDA approves Medtronic's ‘artificial pancreas’ for type 1 diabetes patients

The U.S. Food and Drug Administration today approved Medtronic's MiniMed 670G hybrid closed looped system, the first FDA-approved device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses in people 14 years of age and older with type 1 diabetes.

28 Sep 2016

Separation Technology shifts manufacturing and operations facility from Sanford to Boerne, Texas

EKF Diagnostics, the global in-vitro diagnostics company, announces that Separation Technology, Inc.

From EKF Diagnostics 9 Sep 2016