SEATTLE, WA--(Marketwired - October 22, 2014) -
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Atossa Genetics Inc. (NASDAQ: ATOS) today announced it has received certification to Annex II of the European Medical Device Directive (MDD) 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.
MDD certification verifies that the ForeCYTE Breast Aspirator device meets all applicable directives and standards applicable for its device classification per the directive and has been evaluated and meets the requirements outlined in Annex I, Essential Requirements of the directive. The ForeCYTE Breast Aspirator device is a reusable, hand-held pump device intended for the collection of a small amount of nipple aspirate fluid (NAF) from a woman’s breast for cytological testing (not available in the U.S.). The granting of this “CE” mark involved a comprehensive audit of the company’s quality system as well as a thorough evaluation of the ForeCYTE Breast Aspirator overall design to assure it performs safely. The “CE” mark affirms Atossa’s commitment to product quality and development, and augments its registration to the International Organization for Standardization’s (ISO)13485:2003 “Medical devices - Quality management systems - Requirements for regulatory purposes,” EN ISO 13485:2012 and AC:2012 (Canadian) and ISO 9001:2008 “Quality managements systems - Requirements” standards, which the company received in June 2014.
“This approval marks an essential pivot point for Atossa as we pursue commercialization of the ForeCYTE Breast Aspirator into various European markets,” said Steven C. Quay, Chairman, CEO & President of Atossa. “We are very pleased to attain this important certification as the “CE” mark validates our capability to manufacture and develop a device that meets the applicable regulatory requirements for the European Union,” he continued.
About Atossa Genetics
Atossa Genetics Inc. is focused on improving breast health through the development of laboratory services, medical devices and therapeutics. The laboratory services are being developed by the Company’s subsidiary, The National Reference Laboratory for Breast Health, Inc. The laboratory services and the Company’s medical devices are being developed so they can be used as companions to therapeutics to treat various breast health conditions. For additional information, please visit www.atossagenetics.com.
Forward-Looking Statements
Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with any regulatory actions by the applicable regulatory body for where approval is currently pending for where Atossa intends to conduct business, the outcome or timing of regulatory clearances needed by Atossa to sell its products, responses to regulatory matters, Atossa’s ability to continue to manufacture and sell its products, recalls of products, the efficacy of Atossa’s products and services, performance of distributors, estimated future expenses and cash needs, whether Atossa can launch in the United States and foreign markets the additional tests, devices and therapeutics in its pipeline in a timely and cost effective manner, and other risks detailed from time to time in Atossa’s filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.
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