PERTH, Australia – As D-Day approaches for the European Medical Device Regulations (MDR), Australia is also nearing completion of implementing its own medical device reforms, which closely mirror the EU MDR. “We had to look at aligning as close as possible with the EU system, but we’ve had to align with a moving, incomplete and delayed target, and the TGA asked us to move ahead of the EU reforms,” said John Skerritt, deputy secretary, Health Products Regulation for the Therapeutic Goods Administration (TGA), during the recent Ausmedtech virtual conference.

PERTH, Australia – Australia’s budget theme for the 2021 to 2022 fiscal year is rebuilding the economy following COVID-19, and med-tech and biotech leaders were praising some of the new measures.  

PERTH, Australia – Six classes of medical devices listed on Australia’s Register of Therapeutic Goods (ARTG) will fall under new classification requirements on Nov. 25, 2021, following numerous consultations with industry. The consultations were part of the Australian government’s plans to overhaul its medical device regulations to be more in line with the European Medical Device Regulation (MDR).

PERTH, Australia – Certa Therapeutics Pty Ltd. founder and CEO Darren Kelly knows a thing or two about launching biotech companies. He spun out Fibrotech Therapeutics in 2006 from the University of Melbourne, which was one of the Medical Research Commercialization Fund’s first investments.

PERTH, Australia – The launch of Australia’s first medical device development and manufacturing facility in Melbourne is set to fast-track new treatments for people with conditions such as epilepsy, Parkinson’s disease, hearing loss, stroke and diabetes.

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

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.