Tag: Medical Devices
Lown Reviews: āThe Bleeding Edgeā Documentary
From The Lown Institute: "By the time I finished watchingĀ 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 documentaryĀ āĀ The Bleeding EdgeĀ ā highlights a wide range of systemic flaws in the FDAās regulation of medical devices. As always,...
We Pay a High Price for Unregulated Medical Devices
FromĀ The Lown Institute: New investigations and researchĀ are beginning to show the dangerous consequencesĀ resulting from the FDA's lack of oversight of medical devices.
"It sounds crazy...
āFDA Proposes Reclassifying ECT Devicesā
The Food and Drug Administration (FDA) is attempting to reclassify the electroconvulsive therapy (ECT) device for use in treating severe depression (MDE) or bipolar ādisorderā (BPD). The device is currently a class III device and the proposal is to make it a class II device.