Littleton, CO and Seattle, WA – Mar. 30, 2016
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.”
About dBMEDx™ , Inc.
dBMEDx is a medical device company that is developing novel, automated scanning devices for a wide range of medical applications. The company has developed the world’s smallest, wireless 3D ultrasound scan engine with integrated image analysis capability. This device architecture overcomes many of the limitations of traditional imaging technology to create devices that can be used with very little training by any medical professional. The first commercial product with this technology is the BBS RevolutionTM bladder scanner, the only fully automatic bladder scanner, which is currently being sold in the US. For additional information, please visit www.dBMEDx.com.
David Shine – CEO