FDA Cracks Down on Off-Label Promotion of O2 Chambers

September 5, 2013
The FDA is taking aim at manufacturers of hyperbaric oxygen chambers who claim their products cure conditions ranging from cancer to autism, sending out five warning letters and issuing a consumer alert stating no clinical basis exists for such claims. Hyperbaric oxygen therapy has been cleared by the FDA to treat conditions including carbon monoxide poisoning, diabetic foot ulcers and thermal burns.
Devices & Diagnostics Letter