The U.S. FDA has cleared Cochlear Ltd.’s newest cochlear implant, the Osia 2 system, an active implantable bone conduction hearing system. Unlike Cochlear’s traditional implant, the Osia implant bypasses damaged parts of the ear and sends sound vibrations directly to the cochlea.
PERTH, Australia – On the heels of positive phase IIb data, Melbourne-based Opthea Ltd. announced a private placement of AU$50 million (US$33.87 million) from institutional investors in Australia and the U.K. to advance lead candidate OPT-302 to phase III trials in wet age-related macular degeneration (AMD).
PERTH, Australia – Sydney-based Kazia Therapeutics Ltd.’s shares soared nearly 82% this week on positive interim results for lead molecule GDC-0084 in a phase II glioblastoma trial. Data from the first nine patients in the study show that GDC-0084 treatment resulted in a median progression-free survival (PFS) rate of 8.4 months compared to the standard of care, temozolomide, which has a PFS of around 5.3 months.
MELBOURNE, Australia – Researchers at the Murdoch Children’s Research Institute in Melbourne are pushing the boundaries on creating kidney tissue from stem cells. For more than two decades, Melissa Little and her team at Murdoch have investigated the molecular and cell development basis of kidney disease and the potential for regeneration. The team has developed approaches for directing the differentiation of human pluripotent stem cells to human kidney organoids and is applying that knowledge to disease modeling, drug screening, cell therapy and tissue engineering.
Australia's Therapeutic Goods Administration (TGA) proposed classifying active implantable medical devices (AIMDs), their accessories and active devices for controlling, monitoring or influencing the performance of an active device and software as high-risk class III devices. However, the agency has rethought the notion of up-classifying all implant device accessories after blowback from industry.
Australia's Therapeutic Goods Administration (TGA) recently posted a draft guidance for regulation of software as a medical device, but the Medical Technology Association of Australia expressed a preference for an international standard for risk classification.
Device makers were generally supportive of the Australian Therapeutic Goods Administration (TGA) proposal to up-classify active medical devices with an integrated diagnostic function that significantly determines patient management by the device (such as closed loop systems or automated external defibrillators) to class III, the highest risk designation used by TGA.