Solos Endoscopy is set to develop a new polymer dilator for the MammoView Breast Endoscopy System. The newly redesigned dilator utilizes a polymer housing, which is softer while still offering comparable durability to the metal dilator.
The MammoView System currently offers a dilator set with a metal housing. 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 has also reported that it 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.
Bob Segersten, president of Solos Endoscopy, said: “The new polymer dilator will be a valuable addition to our MammoView system. 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.”