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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.
News For ATOS From The Last 14 Days
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March 5, 2015
09:46 EDTATOSAtossa Genetics receives USPTO patent
Atossa Genetics received a USPTO patent for dynamic methods of diagnosis and prognosis of cancer. Reference Link
February 26, 2015
10:45 EDTATOSHenry Schein Medical to offer Atossa Genetics' FullCYTE Breast Aspirator
Earlier today, Atossa Genetics (ATOS) announced that Henry Schein Medical, the U.S. Medical business of Henry Schein (HSIC), will offer its customers the FullCYTE Breast Aspirator. The Atossa FullCYTE Breast Aspirator is used by OB/GYNs, primary care physicians and women's clinics to collect fluid from breasts for subsequent cytological evaluation. Dr. Steven C. Quay, Chairman, President & CEO of Atossa Genetics, commented, "Working with Henry Schein is an important step forward in making the FullCYTE Breast Aspirator available nationwide. Henry Schein is an industry leader and its multi-channel sales organization allows for expanded reach into multiple market segments within health care for our device. We are thrilled to work with a company such as Henry Schein and believe our arrangement will contribute positively to our upcoming nationwide launch." Shares of Atossa Genetics are up almost 48% in morning trading.

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