Thermo Fisher Scientific Facilities Achieve ISO 13485 Certification
News Apr 04, 2013
The sites in Franklin and San Jose are the first of Thermo Fisher’s liquid chromatography and mass spectrometry sites to achieve ISO 13485 certification.
Thermo Scientific TLX multiplexed HPLC (high performance liquid chromatography) platforms and a number of Thermo Scientific mass spectrometry systems will be designed and manufactured under this standard, paving the way for CE-IVD device registration in Europe and Class-1 medical device listing in the United States, the company said.
“This is a critical step in our ongoing initiative to develop LC-MS-based devices for the clinical market,” said Dan Shine, president of Thermo Fisher’s chromatography and mass spectrometry business. “The medical community is expressing great interest in utilizing LC-MS technology, and we’re aggressively developing tools to address this growing demand.”
New Rapid Test for Valley Fever Should Help Reduce Diagnosis DelaysNews
November saw a spike if cases of Valley fever. Fortunately, the recent—and timely—approval of a new rapid assay test for Valley fever should reduce delays in diagnosing the respiratory fungal infections—a frequent problem in treating the disease, which is caused by spores endemic to soils in the U.S. Southwest.READ MORE
Changes Identified in Body Cells During Type2 Diabetes OnsetNews
Researchers have found fresh evidence to explain the processes that occur in the body’s cells leading to the onset of type2 diabetes. Utilising metabolomics, results showed that amino acids play a contributory role in the onset of type2 diabetes in some younger and older patients, as the metabolism of specific amino acids is adversely affected.
Blood Sample Detection Method for Multiple Sclerosis DiscoveredNews
A method for quickly detecting signs of multiple sclerosis has been developed by a University of Huddersfield research team. The process will avoid the invasive, painful process of collecting fluid from the brain and spineREAD MORE