Industry Briefs
Developments that change the next decision.
Regulatory, research and industry developments affecting cardiovascular medical devices and software—examined for their practical implications.
Regulatory intelligence
Singapore permits two change notifications; but the release sequence still matters
October 23, 2026
Two change-notification applications can create flexibility in Singapore. Their value depends on dependencies, affected listings and implementation conditions.
Read article : Singapore permits two change notifications; but the release sequence still matters
Regulatory intelligence
Australia’s UDI rollout makes stock status a market-access decision
October 22, 2026
Australia’s UDI rollout can treat batches of the same device differently. Manufacturing, labelling and supply history help determine the applicable obligations.
Read article : Australia’s UDI rollout makes stock status a market-access decision
FDA strategy
ECG-MR’s clearance shows the value and boundaries of a PCCP
October 21, 2026
A cleared ECG-MR change plan offers a practical example of connecting future model and compatibility updates to the evidence needed before release.
Read article : ECG-MR’s clearance shows the value and boundaries of a PCCP