Safe Medical Design, a company based in San Francisco, CA, won FDA clearance for its Signal Catheter device. The indwelling foley urinary catheter is designed to help prevent discomfort and injury that can occur if it’s incorrectly placed, an all-too-common occurrence.
Indwelling urinary catheters typically have a balloon at the tip that is inflated once it’s within the bladder. This prevents the catheter from sliding out. When the patient is “dry” and no urine is in the catheter, it’s often difficult to tell whether the catheter tip made it into the bladder, at times resulting in premature inflation that can cause serious trauma.
The Signal Catheter is made of 100% silicone and it features a mechanism that relieves the pressure inside the balloon if it is improperly positioned and inflated inside the urethra.
“This is a monumental shift in a field that has changed very little for the better part of 25 years, despite the over 20 million catheter placements annually in the United States alone,” in a published statement said CEO Dr. David Aaronson, M.D. “Our device, the Signal Catheter™, has the potential to protect patients from unnecessary pain and other complications, while also addressing an issue that costs hospitals $184M annually.”
Product page: Signal Catheter…