PERTH, Australia – Medtech newcomer Artrya Ltd. listed on the Australian Securities Exchange (ASX) in an AU$40 million (US$28.6 million) initial public offering to commercialize its software that analyzes heart computed tomography (CT) scans via artificial intelligence (AI) to better diagnose coronary artery disease.

PERTH, Australia – Six classes of medical devices listed on Australia’s Register of Therapeutic Goods (ARTG) 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 – Australian health technology company Planet Innovation is expanding its footprint into the U.S. with the acquisition of the North American operations of Germany’s medical device manufacturer BIT Analytical Instruments GmbH.

PERTH, Australia – Medical device and analytics company Trajan Group Holdings Ltd. has acquired the business and manufacturing facilities of Axel Semrau GmbH & Co., based in Sprockhövel, Germany, for AU$26 million (US$18.7 million), expanding the company’s global operations. Axel Semrau develops and manufactures laboratory automation and chromatography software and detection systems. The acquisition is the company’s most significant to date and broadens the company’s manufacturing base in Europe, Trajan founder and CEO Stephen Tomisich told BioWorld.

PERTH, Australia – Cardiovascular medical device company EBR Systems Inc. announced a planned AU$110 million (US$79.7 million) initial public offering (IPO) on Australia’s Securities Exchange to bring its wireless cardiac pacing system for heart failure to market. The IPO is planned for Nov. 24, 2021, and the funds raised will allow the company to complete pivotal trials for its wireless, inside-the-left-ventricle-of-the-heart pacing system called WiSE (wireless stimulation endocardially).

PERTH, Australia – Radiopharm Theranostics Ltd. raised AU$50 million (US$36.4 million) in an oversubscribed IPO to advance its platform of radiopharmaceutical products for both diagnostic and therapeutic uses.

PERTH, Australia – Medical device stakeholders generally opposed the Therapeutic Goods Administration’s (TGA) proposal to refine regulation of devices that consist of substances introduced into the human body via a body orifice or applied to the skin. The agency received 45 comments, 17 of which came from medical device manufacturers or associations representing device manufacturers or sponsors, and most of those comments did not support the proposal to refine the regulations.

PERTH, Australia – Radiopharm Theranostics Ltd. raised AU$50 million (US$36.4 million) in an oversubscribed IPO to advance its platform of radiopharmaceutical products for both diagnostic and therapeutic uses.

PERTH, Australia – Australia’s Medical Research Future Fund is pumping AU$40 million (US$29 million) into a national biotech incubator program called CUREator to fund early stage novel therapeutics and preclinical medical research.

PERTH, Australia – Australian researchers have debunked previous research that suggests autism spectrum disorder behavior may be caused by differences in the composition of the gut microbiota.