Health Canada's Medical Device Bureau Completes Evaluation of Solos Endoscopic Instruments for Canada
April 30 2014 - 09:15AM
Marketwired
Health Canada's Medical Device Bureau Completes Evaluation of Solos
Endoscopic Instruments for Canada
BOSTON, MA--(Marketwired - Apr 30, 2014) - 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 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.
Solos Endoscopy, Inc. Investor Relations (617) 360-9719