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August 20, 2014
08:10 EDTATOSAtossa Genetics submits additional information to the FDA in support of ForeCYTE
Atossa Genetics announced that it has submitted additional information to the FDA in response to the FDA's February 21 request. The information was provided in support of Atossa's 510(k) submission for the ForeCYTE Breast Aspirator. The response includes, among other things: Data from an IRB-approved, prospective, single-arm, multi-laboratory, non-randomized, non-masked clinical trial in adult women using the ForeCYTE Breast Aspirator for the collection, fixation, transport, and processing of NAF specimens for laboratory cytological testing at multiple, independent CLIA-registered laboratories. A study of the concordance of positive and negative control Reference Panel Specimens with a blinded cytological interpretation when the specimens were processed and read at multiple, independent laboratories. Study data to establish shelf life information and document shipping stability under adverse conditions of the ForeCYTE Breast Aspirator. Based on the information provided to the FDA, Atossa expects that the FDA will finalize their review process, which may include requests for additional information, and will either clear Atossa's 510(k) submission or provide a "not substantially equivalent" decision on Atossa's 510(k) submission.
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October 22, 2014
08:08 EDTATOSAtossa Genetics receives CE Mark for ForeCYTE breast aspirator device
Atossa Genetics announced it has received certification to Annex II of the European Medical Device Directive from its European Notified Body, DQS Medizinprodukte GmbH, which allows Atossa to place the "CE" Mark on the ForeCYTE Breast Aspirator for distribution in the European Union and its member states. DQS Medizinprodukte GmbH, a Notified Body/Registrar, is also a participant in the FDA's third-party inspection program.

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