All home-use fetal dopplers deregistered following safety review

Reports of false reassurances being linked to stillbirths triggered the TGA review.
Dr Scott White.

The TGA has cancelled all home-use fetal dopplers left on the Australian Register of Therapeutic Goods, warning that the devices may give false reassurances to pregnant women.

A TGA safety review started in 2022 after obstetric services reported three stillbirths and one early neonatal death when patients were falsely reassured by at-home dopplers.

Since then, the sponsors of five devices voluntarily deregistered them and the TGA cancelled the other four, it said on Monday.

However, it is not a blanket ban — companies may still register devices in the future.