BOSTON, Feb. 16 /PRNewswire-FirstCall/ -- Solos Endoscopy, Inc. (Pink Sheets: SNDY) is pleased to announce the Company has designed and is set to develop a new polymer dilator for the MammoView™ Breast Endoscopy System. The MammoView™ System currently offers a dilator set with a metal housing. The newly redesigned dilator utilizes a polymer housing, which is significantly softer while still offering comparable durability to the metal dilator. The new polymer dilator will be offered in addition to the more commonly used metal dilator. The two versions of the dilator offer physicians options based on individual patient's requirements.
Solos Endoscopy has evaluated several firms for the development of the new polymer dilator and is close to making its selection. Solos recently announced that the Company is in the process of creating a quality management system that meets the requirements of the ISO 13485 standard, which is a major step in obtaining the CE Mark and the permission to sell medical devices in the European Union and Canada. As a result of this announcement, candidates for the production of the new polymer dilator had to meet strict qualifications. In addition to their compliance with the FDA's Quality System Regulation, the candidates are also required to be ISO 13485 registered and create a CE Technical File for the new dilator.
"The new polymer dilator will be a valuable addition to our MammoView system," stated Bob Segersten, President of Solos Endoscopy, Inc. "The market for our product has been calling for a dilator that offers less discomfort to patients. We are pleased that Solos can soon offer this alternative."
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.
Safe Harbor: This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 27E of the Securities Act of 1934. Statements contained in this release that are not historical facts may be deemed to be forward-looking statements. Investors are cautioned that forward-looking statements are inherently uncertain. Actual performance and results may differ materially from that projected or suggested herein due to certain risks and uncertainties including, without limitation, ability to obtain financing and regulatory and shareholder approval for anticipated actions.
SOURCE Solos Endoscopy, Inc.
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Solos Endoscopy has evaluated several firms for the development of the new polymer dilator and is close to making its selection. Solos recently announced that the Company is in the process of creating a quality management system that meets the requirements of the ISO 13485 standard, which is a major step in obtaining the CE Mark and the permission to sell medical devices in the European Union and Canada. As a result of this announcement, candidates for the production of the new polymer dilator had to meet strict qualifications. In addition to their compliance with the FDA's Quality System Regulation, the candidates are also required to be ISO 13485 registered and create a CE Technical File for the new dilator.
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"The new polymer dilator will be a valuable addition to our MammoView system," stated Bob Segersten, President of Solos Endoscopy, Inc. "The market for our product has been calling for a dilator that offers less discomfort to patients. We are pleased that Solos can soon offer this alternative."
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.
Safe Harbor: This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 27E of the Securities Act of 1934. Statements contained in this release that are not historical facts may be deemed to be forward-looking statements. Investors are cautioned that forward-looking statements are inherently uncertain. Actual performance and results may differ materially from that projected or suggested herein due to certain risks and uncertainties including, without limitation, ability to obtain financing and regulatory and shareholder approval for anticipated actions.
SOURCE Solos Endoscopy, Inc.
