Atossa Therapeutics Inc (ATOS)

[errett]

chemist72----I'm trying determine exactly how problematic this 510 will be:

"The FDA's warning letter slammed Atossa over its instructions for use, some promotional claims it used for marketing and for not having appropriate clearances for changes made to its nipple aspirate fluid specimen collection process for the MASCT breast pump.

Atossa notes in its recall announcement that MASCT is cleared for fluid sample collection, after which the fluid can be used to determine if cells are normal, precancerous or outright cancer. But the company explains the device hasn't been cleared for breast cancer screening. Sounding contrite, the company also noted that ForeCYTE doesn't have FDA clearance or approval yet "for any indication." The FDA's big worry here is that patients could use both products as a substitute for recommended breast cancer diagnostics or screening and not proceed with the mammograms or biopsies they need.

Appreciate any feedback---tia

ForeCYTE is designed to find precancerous cells and cancer, and help predict the 10-year and lifetime breast cancer risk for women ages 18 to 65. MASCT collects breast fluid noninvasively and then Atossa's lab uses ForeCyte to analyze the results and determine a woman's breast cancer risk in the future."



Read more: Atossa pulls breast cancer Dx after FDA challenges regulatory status - FierceMedicalDevices http://www.fiercemedicaldevices.com/story/atossa-pulls-breast-cancer-dx-after-fda-challenges-regulatory-status/2013-10-07#ixzz2rvNyWNkl
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