Australia’s Therapeutic Goods Administration posted a proposed rework of the agency’s conformity assessment procedures that would align with EU regulations, but the agency stated clearly that it is aware of some of the hazards of further alignment with the troubled European regulations.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accendra Health, Ceribell, Conformal Medical, Gore, Lantheus, Orasure Technologies, Shine Technologies.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brainspace, Intelligent Scopes.
Four optimization trends dominated the med-tech industry in 2025. Growth-driven acquisitions propelled major players into hot markets, while strategic realignments at several large companies prompted notable exits as well as a few tuck-in deals. Spin-offs continued their mixed performance, with several companies on track for significant splits and others changing plans. Private equity entered — and exited — with leveraged buy outs, and a record-setting cash out.
In 2025, the momentum behind robotic-assisted surgical systems continued to accelerate on the back of increasing demand for minimally invasive procedures. In many parts of the world, these technologies are reshaping surgical procedures by improving precision and efficiency through high resolution imaging, AI and refined instrument control. This is resulting in fewer complications, faster recovery and improved patient outcomes.
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