About one in 9,000 females in Australia are diagnosed with Rett Syndrome at birth. In the US, about 15,000 girls and women suffer from it, and globally, this number grows to 350,000 females. The significance of its prevalence is nothing compared to its impact. The disorder can have a detrimental effect on the lives of
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Stamping the letters ‘FDA’ on a Company announcement is a surefire way to flag investors’ interest. Today it was clinical dermatology company, Botanix Pharmaceuticals’ (ASX: BOT) turn to wave the FDA flag following the granting of a new Qualified Infectious Disease Product designation for BTX 1801, an investigational antibacterial product. Focussed on both dermatology and
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There’s been a small bump in the road in Cyclopharm’s (ASX: CYC) plans to secure regulatory approval for Technegas™, their proprietary technology for lung imaging. Technegas™ comprises ultra-fine radioactive labelled carbon that is exposed to high heat to create a gas that can be inhaled by the patient. The gas allows for comprehensive imaging to
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Mental health medtech company Medibio (ASX: MEB) has continued its accelerated plans towards FDA approvals under new management with the company having lodged an FDA application overnight for their mental health screening software – MEBsleep. Having collected the required clinical data MEBsleep (previously named STAGER) tested more than 1,000 individuals using Medibio’s sleep staging algorithm
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As the world battles the coronavirus pandemic, G Medical (ASX: GMV) has secured authorisation from the Food and Drug Administration to sell their Prizma smartphone attachment direct to customers without the need for a prescription, rocketing the company’s share price. Prizma, a smartphone attachment which can monitor a user’s vital signs, can play a vital
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Australian medtech company Cyclopharm (ASX: CYC) is set to add the United States to the list of 59 countries which have approved Technegas®, its nuclear functional ventilation imaging agent, having lodged its New Drug Application (NDA) with the Food and Drug Administration (FDA). As the world’s largest nuclear medicine market in the world, the opportunity
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