jueves, 2 de noviembre de 2017
What you don’t know about the safety and effectiveness of therapeutic ultrasound technologies. Register for the Nov. 9 FDA Grand Rounds for CE credit
Thursday, Nov. 9, 2017
12:00 p.m. - 1:00 p.m.
Greg Clement, PhD
FDA’s Center for Devices and Radiological Health
Ultrasound’s history as a medical tool goes back to the 1940s. Today, diagnostic ultrasound’s ability to image in real-time, along with its excellent safety record and modern-day portability, has led to its prominence worldwide. And the use of high-intensity ultrasound as a minimally invasive therapeutic tool is accelerating. Marketed devices now permit treating certain cancers, uterine fibroids, and essential tremor, while investigations into treating many other brain disorders and various cancers are ongoing. Yet, many of ultrasound’s bioeffects remain poorly understood, with clear implications for assessing the safety and effectiveness of high-intensity therapeutic devices.
FDA is conducting research to better understand ultrasound bioeffects. It aims to identify more accurate metrics for quantifying ultrasound safety and straightforward procedures to assess these metrics.
5 things you’ll learn from this FDA physicist:
1. The role of microbubbles in HITU, and the special safety considerations they introduce.
2. The range of approved and prospective high-intensity therapeutic ultrasound
3. The concept of ‘thermal dose’ for assessing high-intensity therapeutic ultrasound
applications and identify methods FDA is developing to improve its estimation.
4. The limits of what is known about the bioeffects of ultrasound on certain cells, (i.e.
endothelial cells and neurons).
5. The basic methodology behind transcranial therapeutic ultrasound, identify its unique
safety considerations, and discuss FDA development of improved modeling of
ultrasound propagation through the skull.