PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is proposing refinements to the regulation of devices that consist of substances introduced into the human body via a body orifice or applied to the skin.

PERTH, Australia – The FDA gave the thumbs up to Omniscient Neurotechnology Ltd.’s Quicktome, the first brain connectomics planning software that provides neurosurgeons with a digital brain mapping platform to visualize and understand a patient's brain networks before performing brain surgery. By visualizing networks that are responsible for complex functions such as language, movement, and cognition, Quicktome assists neurosurgeons in making more informed decisions and reduces surgical uncertainty.

PERTH, Australia – Rapid point-of-care (POC) diagnostics company Lumos Diagnostics Holdings Ltd. completed a A$63 million (US$47.44 million) initial public offering (IPO) on the Australian Securities Exchange (ASX) on July 5. “The funds raised will support U.S. commercialization of Febridx, to build our pipeline and to expand our operations so that we have the facilities and infrastructure in place to do automated assembly and manufacturing,” Lumos Diagnostics CEO Rob Sambursky told BioWorld.

PERTH, Australia – With FDA approval of its Guardian system to detect early heart attacks, Angel Medical Systems Inc. (Angelmed) will launch the device in the next six weeks in the U.S., and partner Hydrix Ltd. will launch the devices in eight Asia Pacific markets.

PERTH, Australia – Cyclopharm Ltd. said it received a complete response letter (CRL) from the FDA for its Technegas NDA for pulmonary embolisms. The CRL relates to better defining and validating production and delivery of the Technegas particle and other aspects of crucible manufacturing and dosimetry that need to be addressed before the NDA can be approved.

PERTH, Australia – Australia will be phasing out the Astrazeneca COVID-19 vaccine by October and will rely on Pfizer Inc./Biontech SE and Moderna Inc. vaccines to ramp up lagging vaccination rates.

PERTH, Australia – Startup Currus Biologics Pty Ltd. has launched with a AU$10 million (US$7.5 million) series A round with the mission of improving the success of CAR T-cell therapies against solid tumors such as breast, ovarian and pancreatic cancers.

PERTH, Australia – Cyclopharm Ltd. said it received a complete response letter (CRL) from the FDA for its Technegas NDA for pulmonary embolisms. The CRL relates to better defining and validating production and delivery of the Technegas particle and other aspects of crucible manufacturing and dosimetry that need to be addressed before the NDA can be approved.

PERTH, Australia – Researchers at RMIT University and St. Vincent's Hospital in Melbourne have flipped traditional 3D printing to create more intricate biomedical structures, advancing new technologies for regrowing bones and tissue. Instead of making the bioscaffolds directly, the team 3D printed molds with intricately patterned cavities and then filled them with biocompatible materials, before dissolving the molds away.