Achieving the necessary certifications for the approval of the DitchPen™, the first smart nicotine vaporizer for smoking


About 70% of smokers want to quit, but their options are limited, little or not personalized, and ineffective. In recent years, smokers have turned massively to electronic cigarettes in the hope of quitting, but these devices are not considered effective or safe in stopping nicotine addiction.

Ditch is developing the very first medical nicotine vaporizer capable of precisely dosing the delivery of nicotine in order to reduce the doses automatically during a prescribed treatment.

The objective of this project is to certify the components of Ditch’s innovative smoking cessation treatment in order to approve a Class II medical device by Health Canada and the FDA. The standards referred to are ISO 13485, ISO 14971, IEC 62304 as well as the FCC / IC and CE markings.

The project will, at the same time, bring to market the very first technological solution comprising a clinically validated self-assessment tool and personalized treatment based on data collected in real time by a mobile application. This will help, in particular, health professionals working in the medical fields affected by the ravages of tobacco use to obtain, remotely, a better view and understanding of their patients’ addiction in real-time.