BioView Receives Chinese FDA Clearance for DUET Automated FISH Imaging Systems
BioView announced today that it has received clearance from the Food and Drug Administration of the Republic of China (CFDA) for its DUET Automated FISH Scanning and Analysis systems.
BioView’s automated imaging and analysis systems are designed to seamlessly ease the analysis, reporting processes and to reduce turn-around time for labor intensive tests performed by cytogenetic, pathology and cytology laboratories. BioView’s wide portfolio of automated platforms ensures proper fit for laboratory needs, by providing solutions for various sample volumes and automation level requirements.
BioView worked closely with its worldwide distributor, Abbott Molecular, in order to receive the CFDA clearance.
“This clearance is a very important milestone for BioView especially in the context of our commercial relationship with Abbott Molecular”, said Dr. Alan Schwebel, BioView’s President and CEO.
“First and foremost BioView’s advanced products will now be available to Chinese laboratories, which will help them increase their productivity and ensure the highest level of patient care.
Of its main competitors in the Chinese market, BioView is the only one which offers CFDA cleared FISH systems.
Secondly, with this clearance BioView’s products now have regulatory clearance in most major world markets, and can be sold by Abbott Molecular in those markets. We continue to work with Abbott to widen our application portfolio and our worldwide commercial marketing activities.”