dBMEDx Announces FDA 510(k) Clearance of the BBS Revolution™ Bladder Scanner

by PRNewswire

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.

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