Bio-logic's brain monitor cleared for US sale:
This article was originally published in Clinica
The FDA has cleared a new brain monitoring device which records signals from more sites on the brain than existing devices and could be used for more accurate epilepsy monitoring. The Ceegraph device has 132 channels for measuring routine electroencephalograms and for epilepsy and ambulatory monitoring. Bio-logic Systems, which will launch the device in April, said the $40,000 system will compete in the $20 million long term epilepsy monitoring market.
You may also be interested in...
Previous businesses FDA warned about COVID-19 claims for chlorine dioxide, a bleach solution, were marketing dietary supplements unlawfully. But Pro Breath MD's oral rinses available under the Dentist Select and OraCare brands are allowed and FDA isn’t asking the firm to discontinue distribution.
The Stark Law ban on self-referrals wouldn’t apply to some physician owners of advanced imaging facilities under a CMS final rule.
Pfizer’s abrocitinib and Biogen/Eisai’s aducanumab are among a host of new investigational products that are under review by the European Medicines Agency.