The device has been developed to measure bladder volume and provide objective information on the necessity for a urinary catheter.

dBMEDx CEO David Shine said: "Receiving FDA clearance is a pivotal step as we prepare to launch the BBS Revolution device.

"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 company will showcase the bladder scanner at the AORN Surgical Conference & Expo in Denver of Colorado that will take place from 8 to 10 March, and the American Urological Association annual meeting in New Orleans of Louisiana, which will be held from 15to 19 May.

dBMEDx develops and markets automated scanning devices for different medical applications. It has developed the world’s smallest wireless 3D ultrasound scan engine with integrated image analysis capability.