• HeraMED receives Class IIb regulatory classification from the TGA
• HeraBEAT is now the only remote home-use fetal heart rate monitor approved for use in the Australian market
• This approval uniquely positions the HeraBEAT device in the Australian market, potentially providing significant commercial opportunity for HeraMED

HeraMED Limited (ASX: HMD), a medical data and technology company pioneering digital maternity care, has received a new Class IIb regulatory classification from the TGA for its proprietary HeraBEAT fetal heart rate monitor. In July 2022, the TGA began a review of home-use consumer fetal heart monitors (dopplers) in the Australian market, leading to the decision in September 2024 to cancel all such devices. As a result, HeraBEAT was required to reclassify to a higher regulatory classification, which it has now achieved. HeraBEAT is currently the only remote home-use fetal heart rate monitor approved for use in the Australian market, uniquely positioning the device and potentially providing significant commercial opportunity for HeraMED. The HeraBEAT was able to meet the criteria for the higher classification as the device, its use, and the data generated form part of a clinically supervised care plan. HeraMED CEO Anoushka Gungadin stated that the company has actively worked on this reclassification with the TGA, and the resulting market position presents an incredibly unique and exciting commercial opportunity for the proprietary HeraBEAT device. HeraMED now intends to accelerate its Australian go-to-market strategy, targeting large health systems as well as private clinics, to build its market presence in the country.

With the upgraded TGA regulatory classification, HeraMED intends to accelerate its Australian go-to-market strategy for the HeraBEAT device, targeting large health systems and private clinics to build its market presence in the country.