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Tuesday, June 18, 2024 2:08:48 PM
Dr Reddy's Licensed or Partnered with Theranica Bio-Electronics maker of the Nerivio. This is a Distal Transcutaneous Electrical Stimulator. It is a prescription only device selling for around $180 (per the article) for 36 days of therapy if used the recommended 'every other day' for migraine prevention.
Side Effects from the Clinicals are listed as Nausea, Photophobia, and Phonophobia.
Theranica received FDA Clearance for a rechargeable version of the Nerivio called NerivioInfinity in 11/2023. The FDA required no new Clinicals for the rechargeable version,
"No clinical trials were performed with the subject device, given that the therapeutic elements
(electrodes, electrical waveform, location on the body, treatment instructions, treatment duration, etc.)
are the same as in the predicate device."
The 510k for the NerivioInfinity rechargeable took just 3.6 months to get Cleared. This could be good news for the ActiPatch Rechargeable which was mentioned last year.
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