It may only be a matter of time until expectant mothers can monitor the heartbeats of their unborn child from home with medtech company HeraMed (ASX: HMD) pursuing regulatory reclassification to enable their HeraBEAT device to be reinstated for commercial distribution. 

HeraMED is advancing discussions with the Therapeutic Goods Administration (TGA) to reinstate its HeraBEAT foetal heart rate monitor for at-home use. If approved, the device could become the only foetal doppler available for home use in Australia.

The HeraBEAT device, which is designed for pregnant women to monitor their baby’s heartbeat from home without the presence of trained medical professionals, lost its TGA approval in July 2022. This followed the TGA’s extensive two-year post-market review of foetal dopplers, which raised concerns about the use of these devices outside clinical settings. 

The review found that untrained users of consumer-grade devices could misinterpret the results, leading to false reassurance about their baby’s health. As a result, the TGA cancelled all home-use foetal dopplers, including HeraBEAT.

HeraMED’s CEO, Anoushka Gungadin, supports for the TGA’s decision but it also hopeful of HeraBEAT’s future prospects.

“We support the TGA’s decision to remove consumer foetal dopplers without clinical oversight. This opens an exciting opportunity for HeraBEAT as we progress with the reclassification process, which we expect to finalise soon,” said Gungadin. 

HeraBEAT is expected to meet the higher regulatory standards required for reclassification, according to the Company. 

Unlike consumer-grade devices that were withdrawn, HeraBEAT operates within a clinically supervised care plan. Pregnant women are trained by healthcare professionals on how to use the device, and the data is shared in real-time with their medical team via HeraMED’s proprietary HeraCARE platform. This ensures that any potential health concerns are addressed immediately by qualified professionals, offering peace of mind to expectant mothers.

HeraBEAT is unique in its ability to differentiate between maternal and foetal heart rates, a crucial feature for ensuring accurate readings. The device uses a combination of three independent sensors – an ultrasound Doppler sensor for the foetal heart rate, an optical sensor for the maternal heart rate, and smart algorithms that prevent any “cross-talk” between the two. 

HeraMED advertising material claims this level of precision is typically only found in expensive, hospital-grade monitors.

For pregnant women, especially those experiencing anxiety about their baby’s health, the HeraBEAT offers peace-of-mind, particularly in periods of minimal baby movement.HeraBEAT’s ability to share real-time data with doctors enhances this comfort, and the potential to raise alarms where healthcare professionals can intervene if needed.

The reclassification process with the TGA is expected to conclude later this year, with the potential for HeraBEAT to be the sole foetal doppler available for home use in Australia. This could provide HeraMED with a substantial commercial advantage, particularly as its device has already secured regulatory approval in other major markets, including the United States and Europe.