Solos Endoscopy, Inc. Successfully Completes Level I FDA Inspection
Published: Mar 05, 2012
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 conditions. Additional information on its FDA approved products is available on the Company's website at: www.solosendoscopy.com.
Certain statements in this news release may contain forward-looking information within the meaning of Rule 175 under the Securities Act of 1933 and Rule 3b-6 under the Securities Exchange Act of 1934, and are subject to the safe harbor created by those rules. All statements, other than statements of fact, included in this release, including, without limitation, statements regarding potential future plans and objectives of the company, are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Technical complications that may arise could prevent the prompt implementation of any strategically significant plan(s) outlined above. The company cautions that these forward-looking statements are further qualified by other factors including, but not limited to, those set forth in the company's Annual Report filing and other filings with the Pink OTC Markets (available at www.otcmarkets.com). The company undertakes no obligation to publicly update or revise any statements in this release, whether as a result of new information, future events, or otherwise.
SOURCE Solos Endoscopy, Inc.