Urology Devices
Devices for diagnosis and treatment of disorders of the urinary tract and male reproductive system, including BPH therapy, stone management, and continence devices.
Definition
The urology MedTech segment includes BPH (benign prostatic hyperplasia) therapies (laser enucleation, water-vapor, prostatic urethral lift), kidney-stone management (lithotripsy, ureteroscopes, baskets), incontinence and pelvic-floor devices (slings, artificial urinary sphincters, sacral neuromodulation), urodynamics systems, and erectile prosthetics. Class spans Class I catheters through Class III implants.What this means in practice
Reimbursement turns on AUA guideline alignment and CMS coverage for the specific procedure code. Outpatient migration (ASC site-of-service shift) is a major economic driver.- •Assuming a slight energy-modality change qualifies as substantially equivalent without comparative clinical data.
- •Overlooking the AUA practice guidelines that drive payer coverage decisions.
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsImplantable devices that stimulate the nervous system to treat disease.
FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Migration of procedures from hospitals to ambulatory surgery centers.
FDA's most stringent device marketing application, required for high-risk Class III devices.
More in Market Segments
· Same categoryLasers, RF, ultrasound, cryolipolysis, and IPL systems used for medical and cosmetic indications, body contouring, hair removal, skin tightening, vascular lesions.
Software that analyzes medical images to triage, detect, or quantify disease.
Implantable and external devices that monitor and treat cardiac arrhythmias, pacemakers, ICDs, CRT devices, and insertable cardiac monitors.
Devices for diagnosing, monitoring, or treating cardiovascular disease.
Primary references
3 sources- 1
21 CFR 876 Gastroenterology-Urology DevicesVerifiedeCFRecfr.gov
- 2
American Urological Association GuidelinesVerifiedAUAauanet.org
- 3
AdvaMed - Industry ReportsVerifiedAdvaMedadvamed.org
Inline markers like [1] jump to the matching reference above.