Biomerica working with FDA on submission for its IBS product
Irvine, California – September 29, 2015 -- Biomerica, Inc. (OTC BB: BMRA), a global provider of advanced diagnostic products for the early detection of medical conditions, announced today that following a meeting with the FDA on September 17, 2015, Biomerica is now moving forward with guidance from the FDA to develop the optimal clinical and regulatory path to begin clinical studies for its new IBS diagnostic product. The product is intended to aid in identifying patient specific foods that may exacerbate IBS symptoms. The regulatory path Biomerica is pursuing is a De Novo 510(k) which, if accepted by FDA, would allow Biomerica to attain clearance of its product without filing a PMA (Premarket Approval Application). De Novo approval is generally faster and much less expensive than the PMA route, which is the most stringent type of device marketing application required by FDA.
Biomerica has already filed numerous patents for the new technology and it is now patent pending. It is estimated that up to 58 million Americans suffer from IBS in one form or another, and Biomerica feels that many could be helped by this new technology.
“FDA has been very helpful and cooperative in providing us the guidance to develop the clinical trial to validate the accuracy of our new product,” stated Zackary Irani, Biomerica’s CEO. “We are looking forward to working with them to finalize the path for submission. In addition, Biomerica is also exploring regulatory approval in other countries.”
About Biomerica (OTCBB: BMRA)
Biomerica, Inc. (www.biomerica.com) is a global biomedical company that develops, manufactures and markets advanced diagnostic products used at the point-of-care (in home and in physicians’ offices ) and in hospital/clinical laboratories for the early detection of medical conditions and diseases. The Company’s products are designed to enhance the health and well being of people, while reducing total healthcare costs. Biomerica primarily focuses is on products for Diabetes, Gastrointestinal Disease and esoteric testing.
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