HeraMED Limited advised that it has submitted a 510K application to the US Food and Drug Administration (FDA) to seek FDA approval for its medical grade, foetal heart rate monitor, the HeraBEAT. The US Food and Drug Administration evaluates and approves a wide range of items for medical use, including drugs and medical appliances. Being granted 510K approval would mean that the FDA has deemed the HeraBEAT device safe and effective for its intended use in the United States. The United States represents a potentially large addressable market for HeraMED, boasting up to circa 4 million births annually. Following the receipt of the FDA regulatory approvals, the Company expects to enter the United States market, which it anticipates to be in the first half of 2020. Once FDA approval has been granted, HeraMED will liaise with its current R&D collaborator the Mayo Clinic, as well as other medical institutions, hospitals and doctors to drive device uptake.