FDA clears smartphone-connected pelvic floor muscle training device for incontinence

By Aditi Pai
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PeriCoachAustralia-based Analytica has received FDA 510(k) clearance for PeriCoach, its smartphone-connected device that helps women monitor their pelvic floor exercises. The goal of PeriCoach is to reduce or stop urinary incontinence. It will commercially launch in the US next week.

According to the company's website, one in three women experience a bladder leak at some point in their lives. And although experts recommend pelvic floor muscle training exercises to help reduce leaking, Analytica said, "at least 50 percent of women do not correctly contract their pelvic floor muscles with verbal or written instructions alone".

When inserted, the PeriCoach device will detect the strength of each muscle contraction and record each exercise session. The data from the device is sent via Bluetooth to a companion app, which analyzes the exercise data and offers the user a picture of how well she is doing her exercises over time. The app will also send exercise reminders and can send results to a clinician or pelvic health specialist. 

The PeriCoach system will be made available via prescription from a clinician. The entire system, which includes the device, the app, and a 12-month subscription to a data management system, costs $299.

In related news, last week San Francisco-based Lir Scientific announced that they had developed wearable device to help people with incontinence, called Brightly. The device tracks the user’s bladder fullness to help remind people to urinate. Lir Scientific hopes the device will replace adult diapers.

Last year, researchers Professor Takayasu Sakurai and Professor Takao Someya from the University of Tokyo developed a flexible, disposable sensor for adult diapers. The sensor, which can detect moisture, humidity and pressure, is printed on plastic film and will transmit information wirelessly.

In November 2014, London-based Chiaro launched a device, called Elvie, that aims to help consumers accurately do kegel exercises, which strengthen the pelvic floor. That device has not secured an FDA clearance yet though.