Avita Medical Ltd.’s Recell system won FDA breakthrough device designations in soft tissue repair and vitiligo. Melbourne-headquartered Avita, a regenerative medicine company developed the Recell system, a technology platform that enables point-of-care autologous skin restoration.
Radiopharmaceutical company Telix Pharmaceuticals Ltd’s TLX250-CDx (Zirconium (89Zr) TX250) met both primary and secondary endpoints in the phase III Zircon study in clear cell renal cell carcinoma, according to top-line data.
Rainmed Medical Ltd.'s coronary angiography-derived fractional flow reserve system (caFFR system) was approved by Australia’s TGA for precision diagnosis of coronary artery diseases.
Australia’s TGA has opened a consultation on drug-device combination products to help sponsors understand the regulatory pathway through which their products will likely pass since these combination products may not fit within existing definitions for drugs, biologicals or medical devices.
Rapid point-of-care (POC) diagnostics company Lumos Diagnostics Holdings Pty. Ltd. has had its hopes of entering the U.S. market dashed yet again following a second decision from the FDA that Febridx has not demonstrated substantial equivalence to the predicate device identified in its 510(k) application.
Scientists from the University of Queensland have created a new antibiotic that can neutralize various gram-positive bacteria in mice, including major threats such as methicillin-resistant Staphylococcus aureus (MRSA). In a recent study, published in the Sept. 14, 2022, issue of Science Translational Medicine, the new compound outperformed the approved antibiotic vancomycin, and destroyed tough-to-eradicate bacterial biofilms while prompting a low rate of resistance.
For the one in eight couples struggling to conceive, the improvements in infertility treatments achieved by employment of artificial intelligence (AI) in diagnostics, personalized therapies and embryo selection may soon mean the difference between childlessness and the family of their dreams.
Australia’s Therapeutic Goods Administration (TGA) is proposing that devices be subject to good clinical practices (GCP) inspections, and it is proposing two approaches to achieve that goal.
The University of Sydney is investing AU$478 million (US$326.5 million) to build a leading biomedical precinct to fast-track research and shorten the time between discovery and development of transformative therapies.
Women with endometriosis may soon be able to take a simple blood test to determine if they have the condition thanks to a new test being developed by Proteomics International Pty Ltd. that detects up to 78% of women with endometriosis.