Helius Medical Technologies, Inc.
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Latest From Helius Medical Technologies, Inc.
Breakthrough Device That Improves Gait In People With MS Authorized By FDA
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.
Helius Seeks FDA De Novo For Portable Neuromodulation Stimulator For MS Patients
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.
FDA Rejects Helius’ De Novo Application For PoNS To Treat Brain Injury
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.
Global Approvals Analysis: Emerging Markets Drive Volume Of OUS Approvals
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.
- Rehabilitation Equipment and Devices
- Other Names / Subsidiaries
- Heuro Canada
- NeuroHabilitation Corporation (NHC)
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