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Ask The Experts
What is the regulation regarding the use of raw materials not made under GMP or tested by the supplier with non-validated test methods? Is it acceptable to mitigate such perceived issues at one’s supplier with risk analysis-driven performance verification
Our company’s CEO assumes that IVDs are low-risk products and that ISO 13485 certification is merely a marketing tool for EU sales. Thus, satisfying the Notified Body (NB) auditors is important but establishing a functioning quality system is unnecessary.
During installation of an automated urine microscopy analyzer we find that the automat gives higher cell counts pro high power fields than seen under the microscope. The automatic count is equal to that – established with a microscope with the same magnif
Archived Webcast
The Regulation of Companion Diagnostics: Current Status and Updates
Companion diagnostics for personalized medicine is the most important emerging trend in the IVD industry today. In July, FDA released its draft guidance document regarding companion diagnostics, which offers the agency's current thinking on this area. In an effort to provide further clarity on this matter, the editors of IVD Technology have put together a special Webcast on the regulation of companion diagnostics.
Queue 'Featured Content'

Top 10 Molecular Diagnostics Companies

Top 10 molecular diagnostics companies by molecular-related revenues in 2012.

A Risk-Management Roadmap for Clinical Laboratories

Any IVD device can and will fail under certain circumstances. CLSI EP 23 helps labs to manage and mitigate risk. Manufacturers also stand to benefit from knowledge of the guidelines.

Roche Cuts 170 Jobs in Germany and Conneticut

Remaining employees and other resources will be shifted to the company’s diagnostics division.

More Features

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  • In Case You Missed It: Infographic Highlights the Value of IVDs
  • LipoScience, HTG Molecular Diagnostics, BioNano Genomics Named MDEA Finalists
IVDT Insight Blog
Australian Lawmakers Mull IVD Regulatory Changes
Angelina Jolie's Announcement Keeps Myriad Genetics in Spotlight
FDA Approves Lung Cancer Diagnostic by Roche
Cizzle, Fujirebio Join Forces to Develop Lung Cancer Dx
MSU Researchers Develop New Malaria Diagnostic
Abbott Announces CE Mark for Diabetes Dx/Monitoring Test
Aviir Inc. Extends Services with an Inherited CVD Genetic Test Menu
Sequenom's Revenue and Costs Up in First Quarter
Good Start Genetics Receives $28 Million in Financing
Strong Q1 for Mindray Medical Boosted by Diagnostic Sales
IVDT Product News
Cell Fusion System
Monoclonal Antibodies to Chikungunya Virus
Stepper Motor Drive Module
Ultra-Low-Pressure Sensors
Stockroom Inventory Tracking Software
Laser Micromachining
Microflow switch and bubble detector
Target amplification
Mass spectrometry protein analysis
Portable nephelometer
Trends & Perspectives
Your Osteoporosis Test Is in the Nail
Idaho Technology Becomes BioFire Diagnostics, Advances Clinical Diagnostics Goals
European Commission Publishes Guidance on Medical Software Used in IVDs
Ventana Strikes Numerous Deals With Pharma Firms This Year
Our Most-Read Story of 2012: U.S. IVD Market to Exceed $9.5 Billion by 2017
Bill proposes modernizing IVD regulations
FDA To Exempt Some IVDs from 510(k) Clearance
Report offers insights into IVD M&A activity
Samsung Electronics Lengthens its Dx Reach
OCD’s “Know Your Numbers” campaign pushes forward
Most Recent
  • Most Emailed
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Top 10 Molecular Diagnostics Companies
A Risk-Management Roadmap for Clinical Laboratories
In Case You Missed It: Infographic Highlights the Value of IVDs
At HiberGene, Molecular Diagnostics Tackles Meningitis
Your Osteoporosis Test Is in the Nail
The IVD Miniaturization Paradigm
Innovations in Anatomic Pathology Lab Automation
EU IVD Regulation: Something Wicked This Way Comes?
Top 10 Molecular Diagnostics Companies
Our Most-Read Story of 2012: U.S. IVD Market to Exceed $9.5 Billion by 2017
At HiberGene, Molecular Diagnostics Tackles Meningitis
Effect of formulation on lyophilization, part 1
Your Osteoporosis Test Is in the Nail
The IVD Miniaturization Paradigm
Predicting a Positive Outcome for a Negative-Predictive Appendicitis Test
EU IVD Regulation: Something Wicked This Way Comes?
Top 10 Molecular Diagnostics Companies
A Risk-Management Roadmap for Clinical Laboratories
In Case You Missed It: Infographic Highlights the Value of IVDs
At HiberGene, Molecular Diagnostics Tackles Meningitis
Your Osteoporosis Test Is in the Nail
The IVD Miniaturization Paradigm
Innovations in Anatomic Pathology Lab Automation
EU IVD Regulation: Something Wicked This Way Comes?
Top 10 Molecular Diagnostics Companies
A Risk-Management Roadmap for Clinical Laboratories
In Case You Missed It: Infographic Highlights the Value of IVDs
At HiberGene, Molecular Diagnostics Tackles Meningitis
Your Osteoporosis Test Is in the Nail
The IVD Miniaturization Paradigm
Innovations in Anatomic Pathology Lab Automation
EU IVD Regulation: Something Wicked This Way Comes?

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