FDA grants SeaStar Medical Holding a breakthrough device designation for its cell-directed Selective Cytopheretic Device for use in intensive care uni...
Hamilton Medical recalls its Hamilton-C1, T1, MR-1 ventilators because the capacitators may leak electrolyte fluid onto the ventilators control board....
Harvard Medical School professor Jerry Avorn says recent court decisions banning compelled speech could be interpreted to stop FDA from requiring full...
Seven Gibson Dunn attorneys say the government is pursuing False Claims Act cases involving cybersecurity claims by device manufacturers.
BrainStorm Cell Therapeutics says it is withdrawing a BLA for its NurOwn ALS treatment technology and will work with FDA on a path forward for the tre...
Federal Register notice: FDA posts a list of six information collections that have been approved by OMB.
Federal Register notice: FDA determines that Fresenius Kabi USAs Naropin (ropivacaine HCl) solution was not withdrawn due to safety or effectiveness r...
FDA publishes an immediately effective guidance removing an expiration for some enforcement policies for certain non-invasive remote monitoring device...
