Olympus Grabs FDA’s De Novo Status for BPH Treatment
Olympus’ iTind, a nonsurgical device for treating benign prostatic hyperplasia (BPH), has received a de novo classification from the FDA.
The agency grants the designation for novel devices with no existing classification or predicate device on the market.
The iTind is a nonsurgical, minimally invasive device that expands over five days to reshape the prostate and allow urine to flow.
BPH, or prostate gland enlargement, is a common disease in older men that frequently causes lower urinary tract symptoms.