U.S. Food and Drug Administration (FDA) Commissioner Robert Califf ... believe the same will hold true when the tool is an AI/ML based algorithm that may well need approval in its own right.
After combing through 4,000 existing medications, an artificial intelligence tool helped uncover one that saved the life of a patient with idiopathic multicentric Castleman's disease (iMCD).
US-based health technology company ... This system is set to benefit from Anumana's ECG-AI LEF algorithm, which is approved by the US Food and Drug Administration (FDA) and uses routine 12-lead ...
A routine tech checkup revealed the algorithm decayed ... some 20 health-focused AI startups on track to make $10 million in revenue each in a year. The FDA has approved nearly a thousand ...
A PCCP describes what modifications will be made based on the continued ... a change to the underlying AI-DSF that would require subsequent FDA approval. Again, due to the nature of certain ...
In a new draft guidance, the FDA calls on makers of AI devices to describe the sources and demographics of data used to train and validate their products, and disclose blindspots and potential ...
A routine tech checkup revealed the algorithm decayed ... some 20 health-focused AI startups on track to make $10 million in revenue each in a year. The FDA has approved nearly a thousand ...
Tempus AI (TEM) announced the national launch of the company’s FDA-approved, NGS-based in vitro diagnostic device, xT CDx. Beginning today, xT CDx is now available for all ordering clinicians ...
A Mount Sinai-led team of researchers has enhanced an artificial intelligence (AI)-powered algorithm to analyze ... be difficult to universally interpret based on multiple and complex variables ...
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