Solos Endoscopy, Inc. (OTC Pink: SNDY) (PINKSHEETS: SNDY), a provider of quality innovative healthcare instruments to hospitals across the United States, is pleased to announce that Health Canada's Medical Device Bureau (MDB) has completed its initial evaluation of certain Solos Endoscopy instruments and has classified its devices as Class II medical devices.
The Medical Device Bureau examined information with respect to the MammoView Dilator Set, MammoView Cytology Retrieval Kit, MammoView Introducer Set, and the Microendoscope Ductoscope. The review was a necessary step in order to determine the appropriate device classification and in turn apply for the Medical Device License with Health Canada. Solos expects to complete the application this week and the Company will await approval for the Medical Device License in the next 30 days. The Company is currently in discussions with Spectrum Medical Market Consultants to act as its regulatory consultant in Canada for its endoscopic instruments including the MammoView® devices.
Solos Endoscopy recently received its ISO 13485:2003 Certification from TUV SUD America. The Certification to ISO 13485:2003 allows Solos Endoscopy to place the CE Mark on the majority of endoscopic instruments including the MammoView® devices, and make it eligible to apply for its Medical Device Registration in Canada.
The Certification Body of TUV America has certified that Solos Endoscopy has established and is maintaining a quality management system that meets the requirements of the European Union and Canada. The Certification comes at the conclusion of a lengthy Audit with TUV SUD America this past Year. The Audit included a comprehensive review of the Solos Endoscopy's Quality Manual and 28 Quality System Procedures for compliance with the international quality system standard ISO 13485:2003, to the European Union's Medical Device Directive (MDD 93/42/EEC) and to the Canadian Medical Device Regulations (SOR/98-282).
Solos Endoscopy has posted its Certificate from TUV America on its website (http://www.solosendoscopy.com/pdf/solos-iso-certification.pdf).
About Spectrum Medical Market Consultants
Spectrum Medical Market Consultants is a Canadian leader in regulatory and scientific affairs since 1986. Spectrum is a full service consultancy firm providing business, marketing, scientific and regulatory affairs counsel to life science companies. In tandem with Spectrum Alliance Partners™, Spectrum offers its clients a virtual network of experienced professionals. For more information visit www.spectrummmc.com.
About Solos Endoscopy, Inc.:
Solos Endoscopy has celebrated its 25th year of providing quality innovative healthcare instruments to hospitals across the country. For more than 25 years, from medical schools to hospitals, surgeons have trusted Solos Endoscopy to develop and market breakthrough technology, applications, medical devices, and procedural techniques for the screening, diagnosis, treatment and management of disease and 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 OTC Markets Group (available atwww.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.
Solos Endoscopy, Inc.
SOURCE: Solos Endoscopy, Inc.