Monday, April 13, 2009
The Struggle Continues
As we move into the this new year it is interesting to note that the FDA is still grinding it's heels over the ultrasound contrast issue here in the USA. AIUM just wrapped up it's meeting and I will post some highlights:
"Contrast-enhanced ultrasound was a much-talked about topic at the event since it holds great promise. "At the moment, we do have a problem in the U.S. The FDA has approved only two agents for cardiac microbubbles," Dr. Kurtz said. He noted that clinical opinion leaders are talking to the FDA through a multi-specialty task force with vendors to urge further approvals. "The world has access to ultrasound contrast agents; we [in the U.S.] have only limited access," he said, noting its applicability to examining the spleen, liver, and vascular anatomy. Meanwhile, elastography has recently been developed and is being refined to enhance characterization of tumor tissue, also a method applicable to examining liver disease such as chronic hepatitis."
I hope the FDA can come to it's senses pretty soon. The rest of the world embraces ultrasound contrast media. Why can't we?