The FDA gave the go-ahead for an early feasibility study (EFS) to evaluate the safety and feasibility of the investigational device. Alameda, California-based Iota designed the device to deliver electrical stimulation directly to the bladder wall. It induces contractions that facilitate bladder emptying in individuals impacted by underactive bladder (UAB).

According to a news release, the FDA granted a staged approval of the EFS for the novel device. The first stage includes the enrollment of three participants, including at least one male and one female. Following safety outcomes from the first stage, the FDA approved expanding the study to 10 total participants.