There are no home-use foetal heart monitors approved by the TGA for supply in Australia.
Adverse outcomes relating to the use of home-use foetal heart monitors continue to be notified to the TGA.
Using a home-use foetal heart monitor to check a baby’s heartbeat may seem reassuring but it can be dangerously misleading. We have received reports of instances where they have provided false reassurance, leading to delayed medical attention and deaths.
These devices are not a substitute for professional care. We advise consumers to exercise extreme caution when considering using home-use foetal heart monitors to check their baby’s wellbeing.
Action
Home-use foetal heart monitors are handheld devices used to detect or monitor the heartbeat of a baby during pregnancy. These are commonly used by health professionals during antenatal visits. In recent years, home-use foetal heart monitors have become widely available for members of the public.
Following the post-market review of all home-use foetal dopplers completed in September 2024, all home-use foetal heart monitors were cancelled from the Australian Register of Therapeutic Goods (ARTG), meaning, they are no longer approved for advertising or supply in Australia.
However there appears to be ongoing illegal sales online of both new and second-hand devices.
Medical devices which are not included in the ARTG cannot be advertised or supplied in Australia unless subject to a relevant approval, authorisation or exemption.
There are criminal and civil penalties for non-compliance in relation to the supply of therapeutic goods or their advertising.
For consumers
- If you are concerned about your unborn baby’s wellbeing, seek immediate attention from your midwife or doctor.
- DO NOT rely on home-use foetal heart monitors to check your baby’s heartbeat. Home-use foetal dopplers used without specialised training to operate these devices could result in false reassurance of the health of a baby.
For health professionals
- Health professionals are advised to caution expectant parents about the potential risks associated with home-use foetal heart monitors and/or baby movement apps. Specifically, that home-use foetal heart monitors used without specialised training required to operate these devices could result in false reassurance of the health of a baby.
- 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 well-being.
- Include the risks of home-use foetal heart monitors / 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.
Reporting problems
We strongly encourage consumers and health professionals to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. See the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.
If you have concerns about a product’s compliance with TGA’s requirements, report them using the Report a perceived breach or questionable practices form