FDA denies request for over-the-counter Doppler fetoscopes

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The U.S. Food and Drug Administration (FDA) has denied a request that would have permitted over-the-counter access to some handheld Doppler ultrasound fetal listening devices (Doppler "fetoscopes"). Doppler fetoscopes can be made available for use at home but this requires a prescription and is only used for pregnancies that are deemed very high-risk. In its decision, the FDA wrote that "the available scientific literature and the consensus of the scientific community substantiate the current regulatory status of these devices, which provides access for home use when the mother and her physician decide such monitoring is indicated."

The AIUM (American Institute of Ultrasound in Medicine) has come out in support of the FDA’s decision. "AIUM strongly discourages the nonmedical use of ultrasound, and although there are no confirmed biological effects on patients caused by exposure from present diagnostic ultrasound incidents, the possibility exists that such biological effects may be identified in the future," said Lennard Greenbaum, MD, president, AIUM.

In a release, AIUM also stated its belief that there is no notable benefit to consumers from over-the-counter availability of handheld fetal Doppler devices.