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# IDE for Implantable Underactive Bladder Implant
- URL: https://www.fdaweb.com/ide-for-implantable-underactive-bladder-implant/
- Published: 2024-10-14T12:00:00.000Z
- Updated: 2026-09-14T14:43:57.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157973

FDA has approved an Iota Biosciences IDE for an early feasibility study of its investigational implantable device designed to deliver electrical stimulation directly to the bladder wall to induce contractions to help with bladder emptying in individuals impacted by underactive bladder (UAB). Iota says the agency granted a “staged approval”— the first stage will include three participants. The next stage will expand it to a total of 10 participants.

UAB is described as a combination of lower urinary tract symptoms related to detrusor underactivity. Symptoms may include slow urinary stream, difficulty initiating urination, difficulty maintaining the urinary stream and the sensation of incomplete bladder emptying.

Astellas acquired Iota Biosciences in 2020.