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 ...
JD Supra3d
FDA Issues Draft Guidance Documents on Artificial Intelligence for Medical Devices, Drugs, and Biological Products
FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support ...
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The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...
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FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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 ...
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 ...
Becker's Hospital Review12d
FDA issues draft guidance for AI-enabled devices
The FDA has released draft guidance for developers of AI-enabled medical devices, offering recommendations aimed at ensuring the safety and effectiveness of the devices. The guidance, if finalized ...
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 ...
Demystifying AI
The agency wants applicants to demystify their algorithms and provide specific details about what the models do, how they’re ...