Boston, MA 08/20/2014 (wallstreetpr) – According to reports, Atossa Genetics Inc (NASDAQ:ATOS) has submitted additional information to FDA (U.S. Food and Drug Administration) in support of 510(k) submission for the Fore CYTE Breast Aspirator. The company decided to submit the information after the request of FDA, which was placed on February 21, 2014.
What’s the additional information:
Atossa Genetics Inc (NASDAQ:ATOS) expects that U.S. Food and Drug Administration will finish the review process on the basis of information provided by the company. It will either pass the 510(k) submission of the company or will give a “not substantially equivalent” decision on this submission. The management of ATOS has worked very hard on 510(k) report and expected that everything fall in line. According to one of the representatives of the company, “We have done our work in the best possible way, and now hope that FDA will clear our 510(k) submission. We are ready for positive as well as negative decision of FDI.”
Atossa Genetics Inc (NASDAQ:ATOS) is one of the well-known companies in the field of healthcare. The main focus of ATOS is to find out best possible solutions to improve breast health through the development of LDTs or laboratory developed tests. Other than LDTs it also works on development of various therapeutics and medical devices. All the research related activities are executed by The National Reference Laboratory for Breast Health, Inc; a subsidiary of ATOS.
It has got numerous approvals from FDA in the past; therefore, it is expecting the best possible results in this matter as well. Atossa Genetics Inc (NASDAQ:ATOS) recently announced its financial results in which it performed significantly well in terms of sales and EPS. The main objective of ATOS behind developing various LDTs is to facilitate therapeutics with various treatments of breast health conditions. A spokesperson of ATOS said, “We are hopeful that FDA will clear our 510(k) submission. Once we get the results, then only we will be able to give more details about the issue.”
