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Lab tests online to benefit Czech Republic

EDMA, the European Diagnostic Manufacturers Association is proud to announce that the multilingual website, Lab Tests Online is now also available in Czech. The website, an online encyclopaedia on laboratory testing and related conditions, has been developed in Czech by the Czech Society of Clinical Biochemistry, CSKB, in cooperation with the national and European Diagnostics industry associations, CZEDMA and EDMA.

14 Oct 2008

AMDL granted FDA clearance to market blood test for colorectal cancer

AMDL has announced that the US Food and Drug Administration (FDA) has issued a letter of substantial equivalence to an existing predicate device and granted clearance to market the AMDL-ELISA DR-70(R) (FDP) as a safe and effective blood test for monitoring patients who have been previously diagnosed with colorectal cancer (CRC).

7 Jul 2008

Slow growth rate found in overall prices in medical technology sector

AdvaMed, the Advanced Medical Technology Association, has released an important new study that demonstrates the slow rate in growth in overall prices in the highly competitive medical technology sector.

14 Feb 2008

Formal European launch of lab tests online

The formal European Launch of Lab Tests Online, the peer reviewed, patient-centred, non-commercial source of information on laboratory testing, will take place on Thursday, 31 January at La Bibliotheque Solvay in Brussels.

29 Jan 2008

SEBIA joins EDMA corporate membership

EDMA , the European Diagnostic Manufacturers Association welcomes SEBIA as new corporate affiliate, bringing the Association's overall membership up to 33 major IVD companies and 21 National Associations.

12 Dec 2007

Breakthrough innovation for high sensitivity TB and Malaria diagnostics

At this year's 39th World Forum for Medicine in Dusseldorf (MEDICA, November 14-17), Partec, a globally leading developer, manufacturer and provider of dedicated diagnostic solutions in the response to HIV/AIDS, Tuberculosis and Malaria is presenting a breakthrough innovation for high sensitivity TB and Malaria diagnostics in low- and middle-income countries.

From Partec GmbH 15 Nov 2007

EDMA calls for empowering people with diabetes

Type 2 diabetes and its complications are frequently diagnosed too late and the complications are often detected only at the time of diagnosis, concludes the European Parliament in its 2006 Written Declaration on Diabetes.

14 Nov 2007

Roche makes offer to acquire Ventana Medical Systems

Roche will make a tender offer to acquire all outstanding shares of common stock of Ventana Medical Systems for $75.00 per share in cash, or an aggregate of approximately $3 billion on a fully diluted basis.

From Roche Sequencing and Life Science 26 Jun 2007

Roche and Transgene S.A. partner on HPV vaccine program

Roche and Transgene S.A. have announced that they have entered into an exclusive worldwide collaboration agreement to develop and commercialize products from Transgene's therapeutic vaccine program against Human Papilloma Virus-mediated diseases.

11 Apr 2007

In Vitro diagnostic market in Europe

The latest estimates on the In Vitro Diagnostic (IVD) market in Europe, corresponding to the year 2005, are now available.

14 Jan 2007

EDMA welcomes 7 new members

EDMA, the European Diagnostic Manufacturers Association, enlarges its membership with six new companies: BioSystems SA, Diagnostica Stago, Innogenetics, Luminex Corporation, Orion Diagnostica and Tecan, and the Foundation for Innovative New Diagnostics (FIND).

9 Jan 2007

New treatment for lower back pain using patient's own stem cells

A University of Manchester researcher has developed a treatment for lower back pain using the patient's own stem cells, which could replace the use of strong painkillers or surgery that can cause debilitation, neither of which addresses the underlying cause.

From The University of Manchester 2 Dec 2006

New male contraceptive

Men and women have long been promised a male version of the female contraceptive pill. But the first new male contraceptive to market may not be hormonal at all.

8 May 2006

Analysis of the regulatory hurdles in European Diagnostics

In a move aimed at harmonising diagnostics regulations, the European parliament amended the medical devices directive (MDD) of 1993 to bring in the IVD directive (98/79/EC) in 1998.

6 Dec 2005

South African sales of MedMira rapid HIV tests begin

MedMira Inc., the international market leader in rapid flow- through diagnostic technology announced today that it has begun shipment of its MiraWell(TM) Rapid HIV Test to its distributor.

26 Sep 2004

New series of clinical standards to diagnose heart attacks

Diagnosing heart attacks will become a more precise science thanks to the first of a new series of clinical standards just issued by the National Institute of Standards and Technology (NIST). Standard Reference Material (SRM) 2921 (human cardiac troponin complex) will help manufacturers develop and calibrate assays that measure specific protein concentrations in patient blood samples to determine whether a heart attack has occurred.

24 May 2004

New database for U.S. makers of in vitro diagnostic (IVD) medical devices

A new international database has been released that identifies measurement procedures and materials that will help U.S. makers of in vitro diagnostic (IVD) medical devices ensure that their products comply with European Union requirements.

9 Apr 2004