HeraMED Ltd. (AU:HMD) has released an update.
HeraMED Ltd. has announced that following a review by the Therapeutic Goods Administration (TGA), their HeraBEAT device—a home-use foetal heart monitor—will be reclassified to a higher regulatory category. The company supports the TGA’s decision, which aligns with the safety concerns over consumer foetal dopplers used without clinical supervision. HeraMED is actively working towards the reclassification and sees this as an opportunity to solidify HeraBEAT’s unique position in the Australian market as a clinically supervised home-use device.
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