“These are scams,” said Kenny Biddle, the chief investigator for the Center of Inquiry, an organization devoted to defending ...
AI-driven biotech Somite.ai scores dual FDA designations for its novel treatment, potentially fast-tracking hope for families ...
FDA commissioner: Health systems have to ‘step up’ on AI regulation or will ‘end up holding the bag’
Developers can’t fully guarantee the algorithm’s performance, explained Califf, because an AI model’s performance evolves ...
As with all AI applications, the risks stem from bad or biased data. Medical research has historically suffered from the ...
Federal health officials wrestling with when and how to use artificial intelligence will on Wednesday host an invitation-only ...
Avicenna.AI, a medical imaging AI company, has earned FDA clearance for its CINA-CSpine tool, designed to support the detection of cervical spine fractures from CT images, according to a Sept. 19 ...
The U.S. Food and Drug Administration's (FDA) warning letter to Agena Bioscience, issued on March 21, 2024, marks a significant shift in enforcement priorities, targeting the improper labeling of ...
The FDA has declined to approve Vanda Pharma's tradipitant for delayed gastric emptying (gastroparesis), prompting a furious ...
Throughout the workshop, panelists repeatedly emphasized the need for clarity and explicit guidance from regulators around ...
The FDA has granted Orphan Drug and Rare Pediatric Disease Designations to Somite’s cell replacement therapy for the ...
The Food and Drug Administration approved ribociclib plus an aromatase inhibitor for hormone receptor (HR)–positive, ...
The evolving landscape of artificial intelligence (AI) use in cancer care requires evaluation of algorithms before ...
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