Tag: FDA regulations

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FDA Grants Breakthrough Status to Restore Medical’s ContraBand Device

Restore Medical has recently achieved a significant milestone in cardiac care with the FDA granting its ContraBand system breakthrough device designation. This innovative device...
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Limitations of FDA Evaluations on Medical AI Devices | Tech Insights

Researchers have found limitations in the FDA evaluations of medical AI devices. The evaluations are often retrospective and not conducted in multiple clinical sites,...

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