How can staicy capture, analyze and report data of a wearable medical device?
Artificial intelligence researchers at Google claim they have used new software to more accurately predict hospital patient outcomes, including death, discharge and readmission, than is currently possible with existing software, according to a Quartz report.
The FDA today floated some ideas on how it might regulate medical devices armed with artificial intelligence - also known as software-as-a-medical-device (SaMD) - whose algorithms can change based on machine learning (ML) and possibly affect people in ways for which they were not approved or cleared.
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