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FDA Updates Lists of AI and Digital Health Medical Devices

2 months 3 weeks ago

The FDA has updated its lists of medical devices with digital health technologies, including AI-enabled devices, AR/VR medical devices, and sensor-based digital health technology. These FDA-authorized device lists help healthcare providers understand the current digital health landscape and support informed use of advanced medical technologies in patient care.

The post FDA Updates Lists of AI and Digital Health Medical Devices appeared first on In Compliance Magazine.

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AHA Recommends AI Medical Device Safeguards to FDA

2 months 3 weeks ago

The American Hospital Association is urging the FDA to establish regulatory standards for AI-enabled medical devices. The AHA recommends an AI policy framework balancing healthcare innovation with patient privacy protection. AI medical devices have grown significantly in healthcare settings, particularly in diagnostic imaging and radiology applications.

The post AHA Recommends AI Medical Device Safeguards to FDA appeared first on In Compliance Magazine.

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