The FDA has designated Boston, Mass.-based DynamiCare Health’s DCH-001 prescription-only anti-smoking therapeutic software to be a Breakthrough Device.

The software is intended to treat tobacco use disorder to prevent complications in pregnancy and childbirth.

It is based on a motivational incentives approach invented by Stephen Higgins of the University of Vermont. In a published study, the university’s researchers found that pregnant women treated with the DCH-001 digital therapy were 2.8 times more likely to quit smoking by the end of their pregnancy compared to those given the usual care.