Latest Regulatory Clearance News

Imricor Medical Systems has initiated its first MRI-guided atrial flutter ablation procedures at Semmelweis University in Budapest, marking a significant expansion of its real-time MRI technology in Europe.

RBR Group Limited has signed a conditional MOU with Field Ready Group to establish a joint venture focused on employability training in Mozambique, supporting major LNG projects including ExxonMobil’s Rovuma LNG. The venture, through RBR’s subsidiary Futuro Skills, aims to enhance local workforce readiness and economic growth.

Genesis Resources has completed its acquisition of full ownership of the Plavica JV in North Macedonia and is progressing environmental studies and exploration planning for multiple Australian tenements ahead of 2025 drilling campaigns.

CZR Resources has terminated its prior deal with Miracle Iron and endorsed a superior A$75 million cash offer from the Rio Tinto-led Robe River Iron Associates JV for its Robe Mesa Project. The company retains promising gold and titanium-vanadium assets while preparing for shareholder approval.

Orthocell has secured Health Canada approval for its nerve repair product Remplir™, adding the US$75 million Canadian market and expanding its total addressable market to US$1.8 billion. The company plans to appoint local distributors and expects first sales in H2 2025.

Paradigm Biopharmaceuticals has secured ethics approval and appointed a CRO to launch its global phase 3 trial for injectable Pentosan Polysulfate Sodium in knee osteoarthritis, while initiating a substantial capital raising program.

EMVision Medical Devices has secured US ethics approval for its pivotal multi-centre trial of the EMVision emu™ brain scanner, paving the way for a March 2025 trial start aimed at FDA clearance.

Memphasys has completed the final patient visit in its Felix™ clinical trial, with data lock expected within two weeks and preliminary results slated for early March 2025. This milestone paves the way for CE Mark submission and imminent commercialisation in Europe.

Auswide Bank Ltd's shares have been suspended from trading following court approval of its acquisition by MyState Bank Limited, marking a significant consolidation in the Australian retail banking sector.

Sarytogan Graphite Limited has received A$2.36 million from the EBRD as part of a second tranche equity investment, boosting the bank’s stake to 17.3%. An independent peer review affirms the project’s promise while highlighting manageable risks.

Brookside Energy has initiated drilling preparations for the Bruins Well in the prolific SWISH Play, aiming to boost production and increase its working interest to around 70%. This marks the first of three wells planned in its 2025 program, with strong production forecasts underpinning growth ambitions.

Dynamic Metals has secured approval to commence an extensive Reverse Circulation drilling campaign at its Cognac West gold prospect, targeting high-grade anomalies identified in recent sampling. The program, set to begin in early 2025, aims to unlock significant gold mineralisation in Western Australia’s Widgiemooltha region.