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.
You may also be interested in...
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 FAST 01 feasibility trial is evaluating a modification to Varian’s ProBeam particle accelerator that enables ultra-high dose radiation to treat cancer.
Data from the EARLY AF First, Cryo-FIRST and STOP AF trials show cryoablation is a better option than drugs for patients with symptomatic atrial fibrillation.