Tag: Medical Devices
Lown Reviews: “The Bleeding Edge” Documentary
From The Lown Institute: "By the time I finished watching The Bleeding Edge, a new documentary about the medical device industry and regulation, I never...
New Documentary Indicts FDA’s Regulation of Medical Devices
From Forbes: "A new Netflix documentary — The Bleeding Edge — highlights a wide range of systemic flaws in the FDA’s regulation of medical devices. As always,...
We Pay a High Price for Unregulated Medical Devices
From The Lown Institute: New investigations and research are beginning to show the dangerous consequences resulting from the FDA's lack of oversight of medical devices.
"It sounds crazy...
“FDA Proposes Reclassifying ECT Devices”
The Food and Drug Administration (FDA) is attempting to reclassify the electroconvulsive therapy (ECT) device for use in treating severe depression (MDE) or bipolar “disorder” (BPD). The device is currently a class III device and the proposal is to make it a class II device.
