dBMEDx™ , Inc. Announces CE Mark for BBS Revolution™ Bladder Scanner

dBMEDx, Inc., a privately-held, wireless medical device company, announced today that it has received the CE Mark for the BBS Revolution™, a next generation bladder scanner which offers, for the first time, fully automated bladder detection and unparalleled ease of use, speed and accuracy for the non-invasive measurement of bladder volume. This product is currently FDA cleared and is being sold to hospitals and urology offices in the US.

In addition, dBMEDx received ISO 13485 certification for its Quality Management System in accordance with EU requirements and the Canadian Medical Device Conformity Assessment System (CMDCAS).

ISO 13485 certification is evidence of a comprehensive quality management system for the design and manufacture of medical devices. It focuses on risk management activities during product development and guides specific requirements for verification of effectiveness of corrective and preventive actions. It demonstrates a commitment from management for quality throughout the product development life-cycle and the product’s lifespan with customers.

“Now that we have the CE mark for the BBS Revolution™, the company can take advantage of the significant international interest in the product, particularly in Europe and the Middle East.” said David Shine, CEO of dBMEDx. “In the US, the response to the product has been extremely positive for hospitals fighting to reduce catheter-associated urinary tract infections (CAUTI). This is a ubiquitous problem and the international market is primed to welcome the simplicity and automation that the BBS RevolutionTM offers.”