Safe Medical Design, an organization based mostly in San Francisco, CA, received FDA clearance for its Signal Catheter device. The indwelling foley urinary catheter is designed to assist stop discomfort and harm that may happen if it’s incorrectly positioned, an all-too-common incidence.
Indwelling urinary catheters sometimes have a balloon on the tip that’s inflated as soon as it’s inside the bladder. This prevents the catheter from sliding out. When the affected person is “dry” and no urine is within the catheter, it’s typically troublesome to inform whether or not the catheter tip made it into the bladder, at instances leading to untimely inflation that may trigger severe trauma.
The Signal Catheter is a product of 100% silicone and it contains a mechanism that relieves the strain contained in the balloon whether it is improperly positioned and inflated contained in 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.” “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.” in a published statement by CEO Dr. David Aaronson, M.D.