Thermo Registers San Jose Facility with FDA
News Jun 16, 2014
Thermo Fisher Scientific announced that its San Jose, California facility has registered with the U.S. Food and Drug Administration (FDA) as a medical device establishment.
“Last year we achieved ISO 13485 certification for the San Jose site, and this FDA registration is the next major milestone in our ongoing initiative to develop Class 1 mass spectrometry-based instruments for the clinical market,” said Dan Shine, president, chromatography and mass spectrometry, Thermo Fisher Scientific.
Patients in a new Northwestern Medicine study were able to comprehend words that were written but not said aloud. They could write the names of things they saw but not verbalize them. This provides an insight into the brain degeneration that defines the rare dementia termed primary progressive aphasia.
Researchers have developed an artificial intelligence platform to detect a range of neurodegenerative diseases in human brain tissue samples, including Alzheimer’s disease and chronic traumatic encephalopathy. Their discovery will help scientists develop targeted biomarkers and therapeutics, resulting in a more accurate diagnosis of complex brain diseases.READ MORE