IVD News and Research

RSS

Nanoparticle bling could increase sensitivity of test strips for better cancer detection

The most common test strip people might think of for diagnosis is a home pregnancy test. Pregnant women have steadily increasing levels of the biomarker human chorionic gonadotropin (hCG), which is easily detectable in urine and a thin, colorful strip of antibodies will appear when hCG is present.

13 Sep 2017

FDA grants clearance for first 2D digital mammography system with patient-assisted compression

Today, the U.S. Food and Drug Administration cleared the first 2D digital mammography system that allows patients to increase or decrease the amount of compression applied to their own breast before the mammogram x-ray is taken.

1 Sep 2017

Expanding clinical flow cytometry portfolio unveiled by Beckman Coulter at AACC

Beckman Coulter Life Sciences unveils its expanding clinical flow cytometry portfolio at the 69th American Association for Clinical Chemistry.

From Beckman Coulter Life Sciences - Flow Cytometry 28 Jul 2017

Roche receives FDA clearance for new Troponin T test to detect patients with suspected heart attack

Roche announced that it has received the 510(k) clearance for its Elecsys Troponin T Gen 5 STAT (TnT Gen 5 STAT) blood test for patients with a suspected heart attack.

27 Jul 2017

ClearLLab reagents to aid the detection of leukemia and lymphoma receive FDA clearance

Beckman Coulter welcomes FDA announcement for received regulatory clearance to market its ClearLLab reagents for in vitro diagnostic use in the US.

From Beckman Coulter Life Sciences - Flow Cytometry 14 Jul 2017

FDA authorizes marketing of test to aid in diagnoses of serious cancers

The U.S. Food and Drug Administration today allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (MPN).

29 Jun 2017

EKF POCT HbA1c testing confirmed as comparable to lab-based HPLC

EKF, announces recent study confirmed Quo-Test A1c point-of-care testing analyzer comparable to a lab-based HPLC system for the measurement of HbA1c.

From EKF Diagnostics 21 Jun 2017

Illumina introduces fast, highly accurate Veriseq NIPT Solution in the European Union

Illumina, Inc. today announced the launch of the VeriSeq™ NIPT Solution, a CE-IVD marked next-generation sequencing (NGS)-based approach to noninvasive prenatal testing, including CE-IVD marked library prep and analysis software, which enables laboratories in the European Union to bring efficient, highly accurate NIPT in-house.

10 Apr 2017

ITL Group celebrates 40 years of medical device manufacturing

2017 marks a milestone celebration for contract medical device company the ITL Group as they celebrate 40 years in the industry.

From Vitl Life Science Solutions 21 Feb 2017

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.