In 1996, the Food and Drug Administration established the humanitarian device exemption, or HDE, for medical devices.
Companies could gain FDA approval through the exemption by simply showing their product provided a benefit to patients.
The FDA only grants these exemptions to devices that treat conditions affecting less than 4,000 people a year.
The FDA allows companies to sell these exempt devices for profit.
Critics of the process say it puts untested devices into the medical community and companies can use it as a loophole to get their product to market faster.
Today in Healthy Living, a look at some devices recently added to the list.