FDA cites Tennessee company for meningitis light therapy device

As the fungal meningitis outbreak continues, the FDA is citing a Tennessee company for allegedly marketing, without proper regulatory approval, a medical device it claims can cure or treat the condition. Regulators say The Avalon Effect's Quantum Series Personal Wellness Pack qualifies as a medical device under the law, and that Avalon should have submitted a 510(k) prior to selling it. The company claims the device can also treat methicillin-resistant Staphylococcus aureus (MRSA), concussions and Lyme disease. Meanwhile, a meningitis outbreak caused by a drug compounder in Massachusetts continues to have repercussions. Release

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