New Products: Bladder scanner, penile prosthesis, and more
Spacer system designed to protect men undergoing PCa radiotherapy
Waltham, MA—Augmenix, Inc. announced FDA clearance of the SpaceOAR System, which the company said is the first product in the U.S. to be cleared as a spacer to protect the rectum in men undergoing prostate cancer radiotherapy. The SpaceOAR System, a hydrogel product, is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy, creating space to protect the anterior rectum from radiation exposure. Placed through a small needle, the hydrogel is administered as a liquid, but quickly solidifies into a soft gel that expands the space between the prostate and rectum. The hydrogel spacer maintains this space until radiotherapy is complete. The spacer then liquefies and is absorbed and cleared from the body in the patient’s urine.
For more information, visit www.Augmenix.com.
Bladder scanner offers speed, ease of use, accuracy
Littleton, CO and Seattle—dBMEDx Inc. has received FDA approval to market its BBS Revolution bladder scanner. The device offers ease of use, speed, and accuracy for the noninvasive measurement of bladder volume. In addition, the scanner provides rapid, objective information on the necessity for a urinary catheter, according to dBMEDx, which says bladder scanning is a critical component of a catheter-associated urinary tract infection prevention program.
For more information, visit www.dbmedx.com.
Inflatable penile prosthesis approved for ectopic placement
Minneapolis—Coloplast has received approval from the FDA’s Center for Devices and Radiological Health for changes in labeling of the Titan Inflatable Penile Prosthesis instruction for use to incorporate ectopic reservoir placement. According to the company, the approval is the first of its kind, and provides prosthetic surgeons a new, alternative surgical method for men undergoing inflatable penile prosthesis placement.
For more information, visit www.us.coloplast.com.
At-home device helps women manage pelvic floor exercises
Denver—The PeriCoach System, a discreet at-home device and smartphone app that helps women manage pelvic floor muscle training exercises, has received FDA approval. Three biosensors are built into the PeriCoach device to detect the strength of each muscle contraction. Results are instantly sent to a smartphone over a Bluetooth wireless connection. The app collects the readings and gives a picture of how the user is doing over time. It also sends reports from the smartphone to a clinician or pelvic health specialist.
For more information, visit www.PeriCoach.com.