TGA issues grave at-home foetal monitor warning
18 Aug 2025
GPs have been urged to warn expectant parents about the risks associated with at-home foetal heart monitors and baby movement apps, with multiple baby deaths linked to the devices.
The Therapeutic Goods Administration (TGA) has issued a grave warning about the monitors, saying that without specialised training, they can result in false reassurance of the health of a baby.
Following a review of home-use foetal dopplers in 2024, the products are no longer approved in Australia, but they continue to be sold illegally online.
‘Using a home-use foetal heart monitor to check a baby’s heartbeat may seem reassuring but it can be dangerously misleading,’ the TGA warns.
‘We have received reports of instances where they have provided false reassurance, leading to delayed medical attention and deaths.
‘We advise consumers to exercise extreme caution when considering using home-use foetal heart monitors to check their baby’s wellbeing.’
Commonly used by healthcare professionals during antenatal visits, the handheld devices became widely available for at-home use to detect or monitor the heartbeat of a baby during pregnancy.
In response to recent adverse events, the TGA is now calling on GPs to caution their patients over the use of the monitors without specialised training.
‘Advise expectant parents to contact their midwife or doctor and present to a maternity facility or care service for timely review if they are concerned about their unborn baby’s wellbeing,’ it said.
‘Include the risks of home-use foetal heart monitors or baby movement apps in messaging around decreased foetal movements during antenatal appointments and when healthcare professionals are in contact with concerned expectant parents.
‘Continue to reinforce the importance of early contact and/or presentation for concerns, regardless of any perceived reassurance from home-use devices or apps.’
Consumers and health professionals are advised to report problems with the medical devices to contribute to the TGA’s monitoring.