FDA Updates Transparency Lists for AI, AR/VR, and Sensor-Based Medical Devices
- UltraTech Regulatory Updates
- 2 days ago
- 1 min read
The FDA has updated its public registries of medical devices that incorporate digital technologies. These updates cover devices that have received agency authorization for marketing in the United States, reflecting the current state of the digital health landscape.
The agency maintains these lists to provide healthcare providers and the public with a clearer understanding of available technologies. According to the FDA, these resources are intended to support the development of new tools while providing clinicians with information to assist in treatment decisions.
Key Updates Include:
AI-Enabled Devices: An expanded look at medical devices leveraging Artificial Intelligence and Machine Learning (AI/ML) to improve diagnostics and patient care.
AR/VR Technologies: A dedicated list of Augmented Reality and Virtual Reality devices designed for surgical planning, rehabilitation, and medical training.
Sensor-Based Technologies (sDHTs): Updated information on devices that use sensors to capture and transmit health data, facilitating remote monitoring and more precise data collection.
Where to Find More Information:
To explore the specific devices authorized by the FDA, you can access the updated lists directly via the links below:
Contact us for more information.
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