MediBeacon® Transdermal GFR System Receives FDA Approval to Assess Kidney Function
Transdermal GFR System (TGFR) is a first-in-kind product for point of care assessment of kidney function in patients with normal or impaired ...
FDA grants IDE approval for NextBioMedical’s Nexsphere-F trial
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 ...
JD Supra4d
FDA Issues Draft Guidances on AI in Medical Devices, Drug Development: What Manufacturers and Sponsors Need to Know
The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...
ophthalmologyadvisor4d
FDA Alerts: Ophthalmology Drug and Device Approvals
FDA alerts and updates on the latest drug and device approvals, recalls, and other regulatory developments in ophthalmology.
MassDevice4d
The top 10 cardiac device stories of 2024
Cardiac device innovations made waves in 2024, with regulatory approvals, clinical breakthroughs, and product launches ...
GlobalData on MSN4d
FDA grants clearance to icotec’s BlackArmor implants to treat spinal infection
The Centers for Medicare and Medicaid Services (CMS) has approved the implants for New Technology Add-on Payment (NTAP).
JD Supra4d
Streamlining Device Changes with Predetermined Change Control Plans (PCCPs)
In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a ...
Business Wire6d
Simulations Plus Supported Development of Majority of FDA-Approved Drugs in 2024
SLP highlighted its impact on the pharma industry through support of the development of a majority of the drugs approved by ...
FDA Approves Feasibility Study with SeaStar Medical’s Selective Cytopheretic Device in Adults with Cardiorenal Syndrome
Study to be conducted under $3.6 million NIH grant DENVER, Jan. 13, 2025 (GLOBE NEWSWIRE) -- (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the ...