CDRH’s Therapeutic Ultrasound Program is responsible for conducting regulatory science research to ensure patient access to safe and effective innovative therapeutic ultrasound devices. The program is just one of 20 research programs under CDRH’s Office of Science and Engineering Laboratories.
Ultrasound and Medical Device
The medical therapeutic ultrasound devices market is expected to grow in the coming years as the technology is increasingly used for a variety of applications.
The FDA is receiving an increasing number of therapeutic ultrasound device submissions for a wide range of clinical applications including brain, cardiovascular, and pain management. However, gaps remain in the development and characterization of the testing needed to assess clinical safety. Appropriate testing methods that cut across these clinical applications are needed to stimulate innovation and safe adoption of this technology
The Therapeutic Ultrasound Program at the FDA is designed to help manufacturers assess the safety and performance of their devices. This work also makes the FDA better prepared for addressing therapeutic ultrasound devices issues at both the premarket and postmarket stages in the medical device lifecycle.
The Therapeutic Ultrasound Program is focused on researching ways to improve the accuracy of ultrasound measurements and make ultrasound a more effective tool for treating medical conditions. The Program is conducting research in areas such as improving the reliability of hydrophone measurements, developing methods to correct for the effects of spatial averaging, and creating ultrasound-compatible matrix materials. These efforts will help make ultrasound a more precise and powerful tool for diagnosing and treating a variety of diseases.
Source:Therapeutic Ultrasound Program: Research on Medical Devices
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