The 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The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...
FDA alerts and updates on the latest drug and device approvals, recalls, and other regulatory developments in ophthalmology.
Cardiac device innovations made waves in 2024, with regulatory approvals, clinical breakthroughs, and product launches ...
The Centers for Medicare and Medicaid Services (CMS) has approved the implants for New Technology Add-on Payment (NTAP).
In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a ...
SLP highlighted its impact on the pharma industry through support of the development of a majority of the drugs approved by ...
The US Food and Drug Administration (FDA) has approved Zeiss Medical Technology’s MEL 90 excimer laser technology. MEL 90 is ...
Study to be conducted under $3.6 million NIH grant DENVER, Jan. 13, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), ...
SeaStar Medical (ICU) announced that the U.S. FDA has approved an investigational device exemption application to evaluate the safety and ...
The agency wants applicants to demystify their algorithms and provide specific details about what the models do, how they’re ...
There's an urgent push underway to get the U.S. Food and Drug Administration to finally ban the devices that administer electric shocks to disabled students at the Judge Rotenberg Center in Canton.
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