Dude, consider yourself as a patient considering your treatment options. Do you want to be treated with a device that has a "a moderate to high risk to the patient" ....remember that patient is you!!!...or a device that "presents potential unreasonable risk of illness or injury". So I disagree that this "just means that the device had the most stringent review to commercial use approval". You are wrong to assume that more risk means higher cost/profit....it just means more risk. Radiogel is advertised as a lower risk alternative to beads and beads are class II. We need to stay class II.
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