The US FDA has granted de novo authorization to the Portable Neuromodulation Stimulator from Helius Medical Technologies. The PoNS device, previously given breakthrough status by the agency in May 2020, can improve the gait of patients with multiple sclerosis.

The FDA has asked the company for more information to support its PoNS therapy for multiple sclerosis patients with gait deficit, including an additional analysis of clinical data and labeling modifications.

Helius Medical announced on April 10 that the US FDA has declined its de novo application for treating brain injury with its Portable Neuromodulation Stimulator.

The numbers of medical device approvals were up in most regions outside the US and the biggest surge, by percentage, was in approvals from emerging markets and the so-called BRIC countries. It remains to be seen if the trend will continue in 2018, but many companies are already counting on important non-US approvals coming in the next year.