Global Device Approvals, Weekly Snapshot: Transcranial Stimulator For Alzheimer's, And More

25 Sep 2018

• By David Filmore and Reed Miller

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Among the five added this week, Neuronix's NeuroAD Non Invasive Cortical Enhancer technology was approved in Australia for use in Alzheimer's patients, in combination with "tailored cognitive therapy."

Details and links for all five new approvals are included in the table below, and historical data on global device approvals can be found in the full Approvals Tracker. In the US, the table only includes original PMAs, panel-track PMA supplements and de novo classifications. (No panel-track supplements were approved last week by FDA.) During the period, FDA cleared 58 510(k)s, and it approved 8 non-panel-track PMA supplements and 42 30-day notices for certain manufacturing modifications.

Global Device Approvals, Sept. 17-23, 2018