GlobalData on MSN3d
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 ...
STAT10d
FDA pushes makers of AI devices to disclose more details on testing, performance
The FDA wants the developers of medical devices that rely on AI to disclose more detail about how their devices were ...
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 ...
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) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), ...
JD Supra3d
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The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...
SeaStar Medical says FDA approves feasibility study with SCD-ADULT
SeaStar Medical (ICU) announced that the U.S. FDA has approved an investigational device exemption application to evaluate the safety and ...
Community Impact Newspaper3d
Wearable medical devices ‘flipping the script’ on traditional health care
It's been over a decade since the Fitbit was first introduced, and more companies have entered the market for wearable health ...
precisionmedicineonline4d
OIG Recommends Changes in FDA Accelerated Approval After Flagging Concerns With Aduhelm, Other Drugs
The OIG recommended that the FDA define factors that would trigger an application's review by an agency council, which the agency disagreed with.
Info Risk Today12d
FDA Warns of Cyber Risks in Guidance for AI-Enabled Devices
Manufacturers are eager to incorporate AI into a wide range of medical devices, from cardiac monitors that can spot ...