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Solos Endoscopy, Inc. Successfully Completes Level I FDA Inspection

Fri, 03/02/2012 - 10:35am
Bio-Medicine.Org

BOSTON, March 2, 2012 /PRNewswire/ -- Solos Endoscopy, Inc. (OTCPK: SNDY) is pleased to announce that the Company has successfully completed, during the month of February, its Food and Drug Administration (FDA) Level I Baseline Inspection. The Company received a NAI (No Action Indicated) for the inspection.

It is standard for the FDA to periodically perform unannounced inspections for medical device manufacturers and the successful inspection by the FDA validates the Company's quality system and its strict adherence to that system. The site approval accorded by the FDA will enable the Company to continue to supply its high quality endoscopic instrument lines to hospitals, clinics, healthcare centers, medical centers and surgery centers across the United States.

"Compliance to current regulatory standards and guidelines is critical for Solos and its customers. This approval is a true testimony to the high standards of quality, regulatory compliance and operating standards at our company," stated Bob Segersten, President of Solos Endoscopy, Inc.

Solos Endoscopy currently has its endoscopic instruments in over 60 hospitals, clinics, healthcare centers, medical centers and surgery centers across the United States. Solos has focused its R & D efforts into the design and development of new modifications to its endoscopic instrument lines to accommodate the continual advances in laparoscopic surgical procedures. The significant advances over the past several years have led to a number of advantages to the patient with laparoscopic surgery versus an open procedure (laparotomy). These advantages include reduced pain due to smaller incisions and hemorrhaging, and shorter recovery time.

About Solos Endoscopy, Inc.:

Solos Endoscopy, Inc. is a HealthCare instrument company whose mission is to develop and market high quality and innovative instruments for the screening, diagnosis, treatment and management of medical condition

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