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The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...
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 ...
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 ...
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), ...
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones
Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...
MassDevice12d
Alleviant Medical wins FDA IDE, breakthrough nods for no-implant heart failure treatment
Alleviant Medical announced that it received FDA investigational device exemption and breakthrough device designation for its ...