Tag: FDA
RMIT’s ingestible gut sensor wins FDA approval for US market
An innovative gas-sensing capsule developed at RMIT University to provide real-time insights into gut health has received regulatory clearance from the U.S. Food and Drug Administration (FDA), paving the way for its commercial launch in the United States.
Aussie manufacturer ships locally made concussion diagnostic tool to US
Australian MedTech manufacturer Headsafe has commercialised a portable brain injury assessment device called Nurochek, designed to provide faster diagnosis of potential concussions.
Peanut allergy therapy receives $12M boost from Breakthrough Victoria
The Victorian Government announced a $12 million investment in Aravax, a local biotechnology firm, in a push to revolutionise peanut allergy treatment.
3D Systems teams up with biopharma innovator to advance targeted regenerative medicine
3D Systems and Theradaptive, a biopharmaceutical business specialising in targeted regenerative therapeutics, have signed a commercial deal in which 3D Systems will be the latter's sole 3D printing partner.
4DMedical reveals progress in CT-based ventilation-perfusion product
Medical equipment manufacturing company 4DMedical Limited said it has made material progress in the development of its CT-based ventilation-perfusion product (CT:VQ), which quantifies and visualises regional ventilation and regional perfusion.
Immuron prepares for diarrhoea-focused clinical trial as US FDA lifts clinical hold
Immuron, an Australia-based biopharmaceutical company, is slated to move forward with the clinical evaluation of a new oral therapeutic targeting Campylobacter and Enterotoxigenic Escherichia coli (ETEC) following approval from the US Food and Drug Administration (FDA).
FDA OKs manufacturing of Anteris’ aortic valve replacement at Minnesota facility
Anteris Technologies announced that the US Food and Drug Administration (FDA) has approved the manufacturing of DurAVR THV, a 3D single-piece aortic heart valve replacement, at the company's recently expanded production facility in Maple Grove, Minnesota.
Ellume recalls COVID at-home test kits over false positives
As a result of a manufacturing issue resulting in false positives, Brisbane-based biotech firm Ellume has recalled some of its COVID 19 rapid at-home...
Pharmaxis’ locally manufactured cystic fibrosis drug lands in the US
Australian pharmaceutical research company Pharmaxis Ltd (ASX:PXS) exported the first shipment of its locally developed and manufactured cystic fibrosis (CF) drug Bronchitol™ (mannitol) to...
Organovo sets out to develop 3D bioprinted liver for direct transplantation
3D biology company Organovo Holdings, Inc. has unveiled plans to develop 3D bioprinted human liver tissue for direct transplantation.
According to the company, the program...
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Don’t get left behind: Manufacturing’s urgent need for digital transformation
As digital transformation reshapes industries worldwide, manufacturers in Australia and beyond are finding themselves at the forefront of an evolution. This shift presents opportunities for companies looking to improve efficiency, drive innovation, and boost growth.
