dBMEDx Announces FDA Clearance of the BBS Revolution™ Bladder Scanner
LITTLETON, Colo. and SEATTLE, Jan. 6, 2015 /PRNewswire/ -- 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 Revolution, 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 Revolution 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 Revolution 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 Revolution uniquely answers that need with unparalleled ease of use and accuracy."
The BBS Revolution 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.
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 patented dBMEDx architecture automatically collects and analyzes the image data and wirelessly presents the user with a numeric result, bringing the power and safety of ultrasound-based diagnosis to all medical professionals. For additional information, please visit http://www.dBMEDx.com.
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SOURCE dBMEDx, Inc.