In a shocking turn of events, the Therapeutic Goods Australia (TGA) —the medicine regulatory authority in the country—has rejected medtech company Hydrix’s (ASX: HYD) application to distribute its cardiovascular device, Guardian, in Australia. The TGA was dissatisfied with the device’s effectiveness. According to the regulatory body, the AngelMed Guardian device didn’t demonstrate that the benefits
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A heart attack can feel like literally anything. A sore arm, jaw pain, nausea… The list goes on. Difficulty in recognising a heart attack due to atypical symptoms increases for women, elderly and diabetics. The wide scope of symptoms can often result in costly emergency room visits and tests just to discover simple indigestion is
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Since securing the exclusive distribution rights to the AngelMed Guardian device, the only FDA approved implantable heart attack warning system, Hydrix (ASX: HYD) has now successfully implanted the device in four patients in Singapore. Implanted over a 3-day period, patients were selected based on their previous medical history to ensure they would benefit from the
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