Tag: FDA regulations
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...
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,...