FDA tightens its grip on handheld ultrasound

January 1, 2007

The FDA has denied a request for over-the-counter sales of handheld Doppler fetoscopes.

The FDA has denied a request for over-the-counter sales of handheld Doppler fetoscopes. The American College of Radiology and the American Institute of Ultrasound in Medicine, which have aggressively lobbied to stop unwarranted use of ultrasound technology by nonmedical personnel, hailed the decision.

"Patients should understand that ultrasound is very useful, but it needs to be done only when medically necessary. People have to avoid its use for entertainment purposes," said Dr. Carol Rumack, head of the ACR's ultrasound commission.

The FDA's move comes on the heels of a study published by Yale University researchers, who found that exposing pregnant mice to high-frequency ultrasound for 30 minutes or more could result in fetal brain damage.