As we take a look at the devices that received FDA clearance in 2016's third quarter, we're also considering that the last few months have been a time of change at the Food and Drug Administration, as regulators are beginning to make updates in their system to accomodate all the digital health tools we're seeing.
In June, the FDA offered up a draft guidance document designed to help medical...
Analytica's PeriCoach, a smartphone-connected Kegel exercise coach for women, has received a second FDA 510(k) clearance, one that allows it to be sold over-the-counter. Its previous clearance, from March of last year, was for prescription use only.
“This is a terrific achievement for Analytica which opens up a significant market opportunity within the United States, and also positions us...
Australia-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...
