dBMEDx Announces FDA Clearance of the BBS Revolution™ Bladder Scanner

dBMEDx, Inc., a privately-held, wireless medical device company, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its novel bladder scanner, the BBS RevolutionTM , a device offering unparalleled ease of use, speed and accuracy for the non-invasive measurement of bladder volume.

Bladder scanning is a critical component of a comprehensive catheter-associated urinary tract infection (CAUTI) prevention program, an area of intense focus for hospitals given recent Medicare penalties for hospitals with high CAUTI rates as part of the Medicare hospital-acquired condition (HAC) reduction program. Under this program, the Centers for Medicare & Medicaid Services (CMS) are reducing payments by one percent for hospitals with a high number of HACs (including CAUTIs). The BBS RevolutionTM is used to measure bladder volume and provide rapid, objective information on the necessity for a urinary catheter, the primary source of CAUTIs in hospitals.

“Receiving FDA clearance is a pivotal step as we prepare to launch the BBS RevolutionTM device.” said David Shine, CEO of dBMEDx. “With the recent announcement from Medicare regarding penalties for hospital acquired conditions, hospitals will be looking for better, more effective tools to fight CAUTI and the BBS RevolutionTM uniquely answers that need with unparalleled ease of use and accuracy.”

The BBS RevolutionTM will be on display in the dBMEDx booth at the AORN Surgical Conference & Expo from March 8- 10 in Denver, CO and the American Urological Association annual meeting from May 15-19 in New Orleans, LA.