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screwhammer t1_ixuqqf5 wrote

Reply to comment by NotAHost in Stanford Researchers Develop Wireless Smart Bandage That Speeds Up Chronic Wound Healing by Sorin61

FDA approves things as safe and does not seek further proof the thing works as described.

For example, FDA approved oscilococcinum as "safe". This doesn't mean oscilococcinum does anything for your health (it doesn't, homeopathy is a scam) - FDA just says it doesn't do anything bad for you.

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NotAHost t1_ixv2lrm wrote

From my reading, with drugs they have to go through the CDER to be proven effective. There isn't a single approved homeopathic drug, it's just the ingredients that are labeled safe. These ultrasonic bone healing devices are classified as medical devices, so I assume they go through more scrutiny than only safety. A variation can be found here which also has a link to the Exogen system.

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gmabarrett t1_ixv99jb wrote

For medical devices to be ‘approved’ by the FDA they have to demonstrate efficacy.

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WexfordHo t1_ixvi3bd wrote

Homeopathy is regulated as food, medical devices are not and just like pharmaceuticals an efficacy trial is part of the deal.

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