Tag: Medical Devices

Lown Reviews: ā€œThe Bleeding Edgeā€ Documentary

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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

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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

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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...

ā€œFDA Proposes Reclassifying ECT Devicesā€

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The Food and Drug Administration (FDA) is attempting to reclassify the electroconvulsive therapy (ECT) device for use in treating severe depression (MDE) or bipolar ā€œdisorderā€ (BPD). The device is currently a class III device and the proposal is to make it a class II device.