Applied Spectral Imaging Receives China FDA Clearance for BandView® Advanced Imaging Solution
BandView® cytogenetic imaging solution is cornerstone for pursuing additional CFDA clearances.
Carlsbad CA, US and Shanghai, China – October 1, 2015 – Applied Spectral Imaging (ASI) announced today that it has received clearance from the Food and Drug Administration of the Republic of China (CFDA) for ASI’s BandView®.
BandView® is the advanced karyotyping application which is part of ASI’s market-leading imaging platforms, providing enhanced diagnostics workflow and high performance for brightfield, fluorescent and hyperspectral specimens. BandView saves valuable time for medical clinicians and researchers by automating the segmentation of chromosomes, optimizing image quality, and bringing uniquely powerful tools for review, editing and analysis.
“ASI is committed to fully supporting our customers in China. Receipt of this clearance symbolizes a major business achievement for ASI and will assist us in advancing our objective to make Chinese patient care better”, said Limor Shiposh, ASI’s Chief Executive Officer. “This clearance is the cornerstone for pursuing additional CFDA clearances for ASI’s family of comprehensive computer-aided imaging solutions for cytogenetic, pathology and life science research.”
Will-Tek Electro-Optical Ltd, ASI’s distribution partner in Shanghai, played an instrumental role in receiving the CFDA clearance. This regulatory pathway will be used to offer laboratories and research institutions in China ASI’s new, advanced solutions for more efficient and cost-effective workflows.
“Our long-term goal is to maximize customer benefit and usage, while understanding our customers’ clinical needs and perspective,” said Xiao-Miao, Gong, CEO of Will-Tek. “Until today, we have maintained 100% operation and customer satisfaction with ASI products, which confirms ASI product utility and the capability of our service. This CFDA approval reiterates our strong commitment to our customers in China, which will lead to even greater success.”
Will-Tek has worked closely with ASI for over a decade, and currently promotes the complete range of ASI’s GenASIs™ platforms for enhancing cytogenetic and pathology workflows, from interactive to fully-automated scanning and analysis, including remote networking workflows.
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About Applied Spectral Imaging (ASI)
Founded in 1993, ASI is a global leader in the development of imaging solutions for pathology, cytogenetic, and life science research.
ASI’s GenASIs™ automated imaging platforms for pathology and genetic analysis provide advanced diagnostic aids for pathologists and cytogeneticists, with reproducible and reliable results. The GenASIs platform can be used with most brightfield or fluorescence microscopes and supports manual and automatic scanning for a wide range of workflows and applications, to best suit the needs, size and budget of any lab.
ASI’s applications are also US FDA cleared for BandView Karyotyping, FISHView, SpotScan (for CEP XY, UroVysion, ALK and HER2/neu FISH), and HiPath (for IHC Family: HER2, ER, PR and Ki67).
About Will-Tek Electro-Optical Ltd
Will-Tek Electro-Optical Ltd. is the leading scientific instrument company for cytogenetics and pathology in China. With a long-standing culture of stability and sincerity, Will-Tek offers clients the best products and services available together with highly professional standards and execution. With well-trained professionals are located in both Beijing and Shanghai as well as extended branches all over China, Will-Tek provides the best possible performance tailored to each customer. Working closely with ASI for more than a decade, Will-Tek has built up a large expert user base. Will-Tek is promoting GenASIs fully-automated scanning systems as a complete solution for karyotyping and cytogenetics workflow, including remote workflows via the Internet.For More Information Contact: