"The ACR is concerned that Tom Cruise has been badly advised regarding the use and potential abuse of ultrasound. There are many abnormalities that may be missed by the untrained eye. Also, if it is not medically necessary, the use of ultrasound raises unnecessary physical risk to the fetus," said Rumack.

The FDA has also stated, "Persons who promote, sell, or lease ultrasound equipment for making "keepsake" fetal videos should know that FDA views this as an unapproved use of a medical device. In addition, those who subject individuals to ultrasound exposure using a diagnostic ultrasound device (a prescription device) without a physician's order may be in violation of state or local laws or regulations regarding use of a prescription medical device."


"It is disconcerting that a company would sell a medical device to a person not qualified in any way to perform or interpret ultrasound. In medicine, our basic rule has been 'first, do no harm.' No medical procedure is performed or drug given without weighing the risk and the benefit to the patient. If there is no medical supervision for this process, I see no benefit to the patient, which in this case, is Mr. Cruise's unborn child," said Rumack.

Click here to read the ACR position statement on fetal keepsake ultrasound videos. To read the FDA statement of fetal keepsake videos, please click here.

The ACR is a national, professional organization serving more than 32,000 radiologists, radiation oncologists, interventional radiologists, and medical physicists with programs focusing on the practice of radiology and the delivery of comprehensive health care services.

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