Honda announced this week that they received a Medical Devices Directive (Council Directive 93/42/EEC) certification for their Honda Walking Assist Device, an assistive device for use in the training and rehabilitation of walking, which allows Honda to affix a CE mark to their product and market the medical device within the European Union (EU) countries.
This is the first known case of a company traditionally known for automobile, vehicle and engine manufacturing moving into the medical device space. It is unknown as to Honda’s Walking Assist Device timing of entry into the United States markets, which would almost certainly be classified as a powered exoskeleton device that requires FDA 510(k) clearance, but if Honda achieved CE mark in Europe they are almost certainly seeking 510(k) clearance in the United States.
It is an interesting development to say the least and raises the question what other companies not traditionally known for medical devices will enter into US markets with FDA regulated products in 2018.
