PERTH, Australia – Changes to Australia’s medical device requirements have resulted in certain devices no longer requiring TGA conformity assessment certification, including class IV in vitro diagnostics (IVDs). As of July 23, 2021, devices that contain drugs or materials of animal, microbial, recombinant or human origin no longer require mandatory TGA conformity assessment certification. Instead, sponsors of these devices will be able to provide conformity assessment documents issued by notified bodies designated by a European Union member state to support their applications on the Australian Register of Therapeutic Goods (ARTG).

PERTH, Australia – After raising AU$20 million (US$14.62 million) in a series A round, serial entrepreneur Paul Hopper is unveiling his newest venture, Radiopharm Theranostics Ltd., which is developing a platform of radiopharmaceutical and nuclear medicine products for both diagnostic and therapeutic uses.

PERTH, Australia – Engeneic Ltd. has begun a phase I trial of its nanocellular COVID-19 vaccine, which in preclinical animal studies stimulated a broad antiviral response against mutant strains of the virus, including the virulent Delta strain sweeping across Australia.

PERTH, Australia – Engeneic Ltd. has begun a phase I trial of its nanocellular COVID-19 vaccine, which in preclinical animal studies stimulated a broad antiviral response against mutant strains of the virus, including the virulent Delta strain sweeping across Australia.

PERTH, Australia – On the heels of a A$90 million (US$67.12 million) initial public offering on the Australian Securities Exchange, device company Trajan Group Holdings Ltd. has doubled its share price and is well poised for its next stage of global growth. Trajan makes precision consumable products, devices and solutions that used in analyzing biological samples.

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has initiated proceedings in the Federal Court of Australia against Medtronic Australasia Pty Ltd. for alleged unlawful supply of its Infuse bone graft kit, which contains a medicine and other components to stimulate bone growth in patients.

PERTH, Australia – Cardiovascular medical device company Venstramedical Ltd. has raised $2 million in seed funding to support development of a small catheter-inserted collapsible heart pump. The Sydney-based company is aiming to develop devices that provide cardiac support for failing hearts without the use of surgery, Venstramedical co-founder and CEO Martin Cook told BioWorld.

Lightpoint Medical Ltd. is stepping up commercialization activities and collaborating with Telix Pharmaceuticals Ltd. on radio-guided cancer surgery. The companies plan to initiate prostate cancer clinical trials evaluating Lightpoint’s Sensei with Telix’s investigational prostate cancer single photon emission computed tomography (SPECT) imaging agent TLX599-CDx.

PERTH, Australia – As the Delta variant of SARS-CoV-2 sweeps across the globe, drugs like Roche Holding AG’s interleukin-6 receptor inhibitor Actemra (tocilizumab) are being used, often off-label, to treat serious cases of COVID-19. That usage, however, is resulting in serious drug shortages that may leave some without treatment options.