Solos Endoscopy moves one step closer to CE Mark

April 14, 2010 by MassDevice staff

Boston-based endoscopic instruments and imaging equipment maker Solos Endoscopy Inc. completes the first phase of its quality management systems initiative, moving it one step closer to being able to win CE Mark approval in the European Union.

SNDY logo

Struggling imaging equipment maker Solos Endoscopy Inc. (OTC:SNDY) took a "major step" toward gaining access to the European market.

The Boston-based endoscopic instrument maker said it completed its Phase One requirements for compliance with ISO 13485, which denotes a company with a certified quality standards system for developing medical devices. Solos officials said they expect the certification to be completed by the end of the third quarter of 2010.

Completing ISO 13485 is seen as a stepping stone to gaining the CE Mark designation for marketing medical devices in the European Union, which would be good news for Solos' shareholders.

In January, Solos said it planned to release its Q4 and full-year financial results "soon." According to regulatory filings, its full-year 2009 sales should amount to $436,880, up 1.3 percent compared with $431,214 during 2008.

Solos had a rough year in 2009, as the economic climate forced it to sell a pair of product lines back to their original owner.

The company sold its OvaScope and MastaScope product lines, which are used to detect different types of cancer in the breast and ovaries, back to Lifeline Biotechnologies Inc. of Reno, Nev.

Solos purchased the technologies from Lifeline in February 2007, intending to develop a market for the products. But company officials said economic constraints forced them to change tactics and focus on their core suite of endoscopy products instead.