PERTH, Australia – The FDA granted Oncores Medical Pty. Ltd. breakthrough device designation for its quantitative micro-elastography (QME) imaging system. The hand-held imaging tool helps surgeons differentiate between cancerous and healthy tissue in real time at the point of surgery, and it could substantially improve outcomes in breast-conserving surgery (BCS) and reduce repeat operations for women with breast cancer.

PERTH, Australia – Imagion Biosystems Ltd. has entered a collaborative research program with therapeutic antibody development company Patrys Ltd. to combine their technologies to target brain tumor imaging and diagnosis.

PERTH, Australia – After gaining European clearance for its Eugeni COVID-19 rapid antigen test, Anteotech Ltd. reported a A$12 million (US$9.3 million) capital raise to launch its first global product that will help screen travelers, making it easier and safer to open borders. The Brisbane, Australia-based company was largely unheard of before the COVID-19 pandemic hit, but it has emerged as one of the few companies that has developed a low-cost, high sensitivity rapid COVID-19 test.

PERTH, Australia – Advanced Human Imaging Ltd. (AHI) has created an algorithm that allows users to take a few quick scans on a smartphone to create a human avatar of themselves that can calculate risk for certain diseases and help diagnose conditions earlier, while also saving money. The Perth-based company is attracting a lot of attention, announcing three deals in the last week. The imaging technology has a myriad of uses from providing digital health scans to personal training to diagnosing skin cancers.

PERTH, Australia – In response to the COVID-19 pandemic, Trajan Scientific and Medical Ltd. and Synexa Life Sciences Ltd. have developed and validated a SARS-CoV-2 serology assay that enables more efficient, population-based monitoring of the longevity of COVID-19 vaccines being deployed and to help determine the timing and deployment of booster vaccinations.

PERTH, Australia – Implicit Bioscience Ltd.’s lead candidate, IC-14, is the first anti-CD14 monoclonal antibody (MAb) to progress to the clinic as it enters a phase II trial in the U.S. in COVID-19 patients. 

PERTH, Australia – The Australian government is recommending that Australians under 50 take the Pfizer Inc. COVID-19 vaccine due to the risk of rare blood clots associated with Astrazeneca plc’s COVID-19 vaccine (ChAdOx1-S). The move jeopardizes Australia’s vaccine rollout as it had planned for the majority of Australians to receive the Astrazeneca vaccine, which is being locally manufactured by CSL Ltd.

PERTH, Australia – In the aftermath of the COVID-19 pandemic, Australia is shoring up its national supply of medical products and making it a national priority to drive economic recovery and ensure future resilience. The objective of the government’s modern manufacturing strategy is to build scale and capture income in high-value areas of manufacturing where Australia either has established competitive strength or emerging priorities.

PERTH, Australia – Australia’s TGA issued final guidance on clinical evidence requirements for medical devices in response to updated regulations that have resulted in changes to evidence requirements. Clinical evidence is required for all medical devices and in vitro diagnostics (IVDs) that are listed on the Australian Register of Therapeutic Goods (ARTG). The clinical evidence requirements apply when a device is first listed as well as over the lifecycle of the device. If safety issues are identified, the TGA may ask manufacturers to update clinical information to more accurately reflect risk.