Category: Food & Drug Administration (FDA)Syndicate content

FDA clears Neuronetrix portable EEG device

February 24, 2015 by Val Kennedy

The FDA has cleared Neuronetrix's portable device for the recording of electrical brainwaves in patients with neurological conditions such as Alzheimer's disease, concussion, schizophrenia and ADHD.

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The FDA has cleared Neuronetrix's portable device for the recording of electrical brainwaves in patients with neurological conditions such as Alzheimer's disease, concussion, schizophrenia and ADHD.

The device, called the Cognision System, is designed to run brainwave tests such as EEGs and auditory event-related potentials (ERPs). Neuronetrix said the device allows doctors to run tests in their offices that used to be only available in a hospital setting.

Varicose vein treatment: VenaSeal wins FDA approval

February 20, 2015 by Brian Johnson

Federal regulators say they have approved the VenaSeal closure system to treat varicose veins

Covidien study: VenaSeal effective in treating leg veins

Covidien's VenaSeal closure system to treat varicose veins has been approved by the U.S. Food and Drug Administration, according to an agency press release.

FDA approves 23andMe's genetic screening test for rare disorder

February 20, 2015 by MassDevice

Google-backed 23andMe won U.S. approval to market direct-to-comsumer genetic test

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(Reuters) - Google (NSDQ:GOOG)-backed 23andMe won
U.S. approval on Thursday to market the first direct-to-consumer
genetic test for a mutation that can cause children to inherit
Bloom syndrome, a rare disorder that leads to short height, an
increased risk of cancer and unusual facial features.

FDA clears Dallen's Tensyn Plug

February 20, 2015 by Val Kennedy

Dallen Medical's Tensyn Plug for the treatment of hand and foot injuries wins 510(k) clearance.

FDA clears Dallen Medical's compression band to repair bones

The FDA has cleared Dallen Medical Tensyn Plug for the treatment of hand and foot injuries.