MASSDEVICE ON CALL — The FDA issued a 2nd warning to light-based therapy devices maker The Avalon Effect Inc. for unregulated claims that its devices can cure or treat symptoms of fungal meningitis, MRSA, concussions, Lyme disease, and other diseases.
"Consumers should be aware that, especially during disease outbreaks or other public health crises, they may see opportunistic advertisements for products touted as cures or treatments," FDA Center for Devices & Radiological Health compliance director Steve Silverman said in prepared remarks. "Bogus medical claims can actually harm consumers by causing them to delay seeking treatments that have been proven to be safe and effective."
The FDA originally issued a warning to The Avalon Effect on August 15, but was not satisfied with the response it received from the company in September when an agency review of the Avalon site and linked sites continued to contain illegal claims.
The Avalon Effect appears to have removed the offending claims at this time, according to a MassDevice.com review.
The Avalon Effect markets light therapy devices for "multiple therapeutic benefits," according to an FAQ on the company’s website.
The medical devices behind the record-breaking Red Bull Stratos free-fall
Team members working on Red Bull’s record-breaking Stratos free-fall jump talk about the medical devices that kept sky-diver Felix Baumgartner alive and monitored his vital during the 128,100-foot free-fall.
Read more
Connecting vascular disease to Alzheimer’s
Researchers connect increased risk of Alzheimer’s disease to vascular diseases such as hypertension, Type II diabetes and heart disease, according to the results of 15 years worth of data.
Read more
Newer docs cost the most, study says
Less experienced physicians regularly spend "significantly" more on treating patients than those with the most experience, according to a new study from the RAND Corporation.
Read more
