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.
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.
Regenerative medicine company Avita Medical Ltd. reported that topline results were mixed for its pivotal trial evaluating the safety and effectiveness of its Recell system combined with meshed autograft for reducing donor skin harvesting in soft tissue reconstructions.
Western Australia’s private investment group Tattarang has launched a new AU$250 million (US$173.6 million) investment fund called Tenmile that will invest in early stage Australian biotech and med-tech companies. One of Australia’s largest private investment groups, Tattarang is owned by the Forrest family and has five business divisions made up of real estate, agriculture, energy, mining and hospitality.
The FDA granted Adherium Ltd. 510(k) clearance for its next-generation Hailie sensor that connects with Glaxosmithkline plc’s Ellipta inhaler to enable monitoring of medication use for asthma and chronic obstructive pulmonary disorder (COPD).
Rapid point-of-care (POC) diagnostics company Lumos Diagnostics Holdings Pty. Ltd. saw its stock plummet 65% on the news that the U.S. FDA rejected its Febridx 510(k) because the device was not substantially equivalent to the predicate device.