Australia’s Therapeutic Goods Administration (TGA) made significant changes to some of its regulations, including those for software-based medical devices. The TGA said that entities that are switching their products to a higher risk classification can continue to offer them for six months after Nov. 1, 2024, if they have an application on file with the TGA, but only if the sponsor notified the agency of such intent prior to May 25, 2022.

Serac Imaging Systems Ltd. is seeing encouraging results from ongoing trials at three sites, which are comparing its Seracam portable hybrid gamma-optical camera for medical imaging to standard of care nuclear medicine imaging, Mark Rosser, CEO of the company, told BioWorld.

Nearly 80% of people in Australia and the U.S. that used Genetic Technologies Ltd.’s Genetype multi-risk assessment test showed an elevated risk for at least one disease covered by the test.

Confidence in working with Chinese biopharma companies has dropped by 30% to 50% for U.S.-based life sciences companies, with Chinese contract development and manufacturing organizations the hardest hit, according to a recent LEK survey of global life sciences companies on the impact of the pending U.S. Biosecure Act.

Radiopharm Theranostics Ltd. announced a AU$70 million (US$46.69 million) institutional placement, and as part of that capital raise, radiopharma company Lantheus Holdings, Inc., has agreed to make an initial equity investment of AU$7.5 million.

Nexsen Biotech Pty Ltd. developed a rapid diagnostic test for Group B Streptococcus, a highly prevalent and potentially fatal bacteria that is the single largest maternal health problem faced by pregnant mothers.

Radiopharm Theranostics Ltd. announced a AU$70 million (US$46.69 million) institutional placement, and as part of that capital raise, radiopharma company Lantheus Holdings, Inc., has agreed to make an initial equity investment of AU$7.5 million.

On the heels of a $7 million seed round, Singapore-based medical technology startup Thrixen Pte Ltd. is accelerating development of its diagnostic technology platform that has the potential to perform multiplex diagnostic tests at the point of care.

Inosys Korea Co. Ltd. gained U.S. FDA 510(k) clearance for Unispace, a cervical spine cage manufactured with 3D printing technology. Unispace can be used during spinal fusion surgery, Busan-based Inosys said, wherein operators can remove a patient’s diseased or damaged disc and replace it with the cervical cage to maintain the original length of the spine.

In just its second PCT filing, Ykrita Lifesciences Private Ltd. (YLS) continues to assemble intellectual property for its development of an extracorporeal bioengineered dual-cell liver regeneration (EBDLR) system which serves as a lightweight, portable, ectopic liver device to aid in the rejuvenation of the body’s own liver and treat acute liver failure without the need for surgery.