Latest Regulatory Clearance News

Macmahon will acquire Aspect Engineering Solutions for a headline enterprise value of A$75 million, adding engineering, minerals processing and project delivery capabilities to its mining services platform. The deal is expected to lift underlying EPS by about 6.2% from inception, although completion and future earnings performance remain important variables.

Reliance Worldwide Corporation has signed a binding scheme implementation deed for Brookfield to acquire all shares for US$3.38 each, equivalent to about A$4.75 at the stated exchange rate. The recommended deal now enters a limited window for rival proposals before shareholder, court and regulatory approvals are sought.

CurveBeam AI has secured FDA 510(k) clearance for CT-based bone mineral density measurement, establishing the first regulatory step towards a potential new SaaS offering. The more commercially significant HiRise weight-bearing application still requires a separate clearance.

Alcoa has filed South32’s meeting materials ahead of a shareholder vote on the proposed sale of bauxite, alumina and aluminium interests. The transaction remains subject to shareholder approval, regulatory clearance, financing and other closing conditions.

The FDA has agreed that EBR Systems’ WiSE cardiac pacing system does not require a field corrective action or recall following a February cybersecurity incident. The device maker says it has found no evidence of any impact on the safety or performance of fielded systems, while remediation work continues.

EBR Systems has secured ISO 13485 certification for its new Santa Clara manufacturing site, paving the way for a 500% increase in WiSE System production pending FDA approval expected by year-end.

Arovella Therapeutics has released the first clinical batch of its off-the-shelf cell therapy ALA-101 and activated its inaugural trial site at The Alfred, setting the stage for patient dosing later this month.

Alcoa Corporation has filed to register shares of its common stock to be issued in connection with its $4.1 billion acquisition of South32 Limited’s upstream aluminum assets, spanning Australia, Brazil and South Africa. The deal includes cash, stock consideration, and contingent payments linked to commodity prices, pending customary approvals and shareholder support.

CurveBeam AI’s FY2026 results show a 28% revenue decline and a 12% increase in net loss, while advancing its China commercialisation and robotic surgery integration strategies. The company also announced a $6-7 million capital raise post-year-end.

Singular Health Group lifted revenues over fivefold to $1.43 million in FY26, driven by US commercial rollouts of its 3DICOM platform, but posted a $6.34 million loss. The company strengthened its US foothold with FDA clearance and a controlling stake in an associate.

Heartland has cleared a major hurdle in its $620 million acquisition of TSB, with Toi Foundation trustees approving the sale. The merger aims to create a stronger regional challenger bank, pending shareholder and regulatory green lights.

Acrow Limited secures final ACCC approval for its AusGroup Industrial Services acquisition, clearing the path for completion on 1 September 2026 and strengthening its foothold in Australia’s civil infrastructure sector.