Payers had their hands full in 2025 dealing with the raft of medical technologies that came through the globe’s regulatory review processes, although the nature of many of those challenges were conventional. On the other hand, payers struggled to keep pace with both the volume of conventional devices and the novelty of AI-driven devices in 2025, a problem that will carry over into the coming year.
Epiminder Ltd. raised AU$125 million (US$82.99 million) in its initial public offering on the Australian Securities Exchange to commercialize its Minder system, a long-term ambulatory electroencephalography monitoring device for epilepsy.
Saluda Medical Pty Ltd. announced a AU$231 million ($152.7 million) initial public offering on the Australian Securities Exchange to scale up its U.S. footprint for its Evoke spinal cord simulation system for chronic pain.
Australia’s Therapeutic Goods Administration has made a few adjustments to its advertising guidelines for social media promotions, including the requirement that the manufacturer is responsible for anything posted by influencers who are acting on behalf of the manufacturer.
The largest study ever conducted on light therapy for Parkinson’s disease has found that long-term use of Symbyx Biome Pty Ltd.’s non-invasive, at-home photobiomodulation (PBM) devices significantly improved mobility, anxiety, and overall symptom severity.
As Royal Philips NV works to rebuild trust after a global device recall, it is investing in new models of access, affordability, and technology to close gaps in sleep apnea diagnosis and therapy across Asia.
Xtalpi Inc. has announced regulatory clearances in Australia and Taiwan for phase I trials of PEP-08, a next-generation PRMT5 inhibitor candidate developed under its AI drug discovery collaboration with Pharmaengine Inc., for solid tumors. This milestone triggered a payment to Xtalpi under the partnership agreement.
Patients often wait for a long time to see a mental health specialist to get the help they need, and Greymind AI’s mental health platform, Reboot AI, offers a stop-gap measure to provide structured early intervention with built-in escalation to human clinicians.
Australia’s Therapeutic Goods Administration recently reported that it has concerns about the use of digital scribes, stating that any such software that analyzes or interprets clinical conversations may qualify as a regulated medical product.
Australia’s Therapeutic Goods Administration reported June 30 several new regulatory requirements are in effect, including a new mandate regarding the use of unique device identifiers for implanted medical devices.
