“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 ...
Throughout the workshop, panelists repeatedly emphasized the need for clarity and explicit guidance from regulators around ...
SoundHealth launched a new feature in its AI-powered health care app that will give users personalized allergy forecasts to ...
The FDA has declined to approve Vanda Pharma's tradipitant for delayed gastric emptying (gastroparesis), prompting a furious ...
The FDA still views AI regulation as an evolving science that is highly specific to each device and its intended use, he said. As the FDA continues its work to ensure that AI is deployed safely ...
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, ...
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