MassDevice2h
Stereotaxis Magic ablation catheter is now CE mark approved
Stereotaxis said today that it has secured CE mark approval for its Magic robotically-navigated magnetic ablation catheter.
FDA spars with Waco company over ‘unapproved’ and ‘unlicensed’ human amniotic products
Federal regulators have warned a Waco company that its human amniotic products are “unlicensed” and “unapproved,” and that ...
Newly FDA-approved COVID-19 treatment helps protect immunocompromised
A big step forward in COVID-19 treatment and a breakthrough for a Florida-based nonprofit blood center serving the southeast. OneBlood just became the first blood center to get full FDA approval to ...
MassDevice4d
FDA adds RevMedica stapling platform to STeP program
RevMedica announced that the FDA accepted its Endo stapling platform into its Safer Technologies Program (STeP).
FDA bans Red No. 3, but experts warn of ongoing gaps in food safety regulations
The Food and Drug Administration announced last week that it will revoke authorization for FD&C Red No. 3 in food and ingested drugs under the Delaney Clause of the Federal Food, Drug, and Cosmetic ...