The U.S. Food and Drug Administration approved Amgen's combination therapy on Thursday to treat colorectal cancer in patients ...
CergenX announced today that the FDA granted breakthrough device designation for its Wave device for neonatal brain ...
Study to be conducted under $3.6 million NIH grant DENVER, Jan. 13, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), ...
Stockhead on MSN5h
Health Check: Investor hearts pump as EBR girds for US approval of novel pacemaker leadsEBR Systems is girding for US FDA approval of its novel heart lead in April and commercialisation by the end of the year.
In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a ...
Hosted on MSN4h
EBR’s US heart lead hopes tick up after wireless device gets nod for fast-track reimbursement pathwayCMS has accepted EBR's WiSE cardiac resynchronisation therapy (CRT) system into the fast-track TCET reimbursement pathway. ..
Cardiac device innovations made waves in 2024, with regulatory approvals, clinical breakthroughs, and product launches ...
SeaStar Medical (ICU) announced that the U.S. FDA has approved an investigational device exemption application to evaluate the safety and ...
GlobalData on MSN3d
FDA grants IDE approval for NextBioMedical’s Nexsphere-F trialThe US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval for NextBioMedical's randomised trial involving its fast-resorbable embolic microsphere, Nexsphere ...
The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...
Federal health officials on Thursday backed the public health benefits of nicotine pouches, authorizing Philip Morris ...
The FDA is reviewing new vaccines for meningitis and chikungunya and therapies for Parkinson disease and PTSD.
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