Device Classifications: US FDA Orders Special Controls For Treatments For ADHD, Weight Loss, More
Executive Summary
The device classification announcements include four class II devices, as well as one that was placed in class I.
You may also be interested in...
FDA Announces Class II Status For 6 New Device Types
The newly classified devices were initially authorized via the de novo pathway.
US FDA Classifies 5 De Novo-Cleared Device Types
The five products include a conditioning tool for eating disorders, a system that evaluates the properties of esophogeal tissue, and a tool used to measure the strain on an orthopedic implant during surgery.
Report Finds Digital Diabetes Tools Deliver No ‘Meaningful Clinical Benefits'
A new report from health economics group the Peterson Health Technology Institute found that apps to help patients manage their blood sugar levels delivered few of the promised benefits. However, a digital therapeutics industry association says PHTI’s research cast too narrow a net.