Latest Regulatory Reviews News

Optiscan Imaging has lodged a US FDA 510(k) application for InVue, its precision surgery device designed to provide cellular-level imaging during operations. The submission moves the technology into formal regulatory review, but clearance and commercialisation remain uncertain.

Optiscan Imaging has lodged a 510(k) submission for its InForm digital pathology device, moving the product from development into formal US regulatory assessment. FDA clearance is not assured, but a successful determination could open the door to commercial distribution in the company’s target market.

Dimerix has drawn A$17 million from a non-dilutive facility, giving the biotech funding it says is sufficient to complete the ACTION3 Phase 3 trial of DMX-200 and continue developing DMX-652. A further A$17 million remains available, although repayment depends partly on future licensing income, milestones or capital-market access.

AdAlta has secured a formal US FDA pre-IND meeting for EW-001, moving its mesothelioma CAR-T therapy into a critical regulatory review. The November meeting will test the company’s Australian manufacturing, remaining studies and proposed Phase 1 trial before the more expensive stages of development begin.

DPM Metals has extended its Brevene Porphyry South discovery with long, high-grade gold-copper-molybdenum intercepts, including 716.6 metres at 3.30 g/t gold equivalent. Mineralisation now reaches the Chelopech mine concession and remains open in several directions and at depth.

Cleo Diagnostics has appointed Bio-Techne’s CLIA-certified U.S. laboratory Asuragen to run pivotal clinical validation for its pre-surgical ovarian cancer test. The approximately 1,470-sample program is intended to generate the evidence supporting a planned FDA 510(k) submission in the first half of calendar 2027.

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.

OncoSil Medical has moved closer to local production after contract manufacturer Cyclotek secured ISO 13485 certification for its quality management system. Production at the Macquarie Park facility remains targeted for the end of 2Q FY27, subject to further regulatory approval.

Australasian Metals has locked in a three-month exclusive option to acquire majority stakes in two promising lithium projects in Côte d'Ivoire, marking a strategic move into West Africa's emerging critical minerals scene.

Cleo Diagnostics has received its first commercial batch of ovarian cancer test kits from Bio-Techne, marking the start of analytical validation critical for its FDA submission planned in early 2027.

Island Pharmaceuticals has obtained regulatory rights to reference critical Marburg-Angola virus natural history data, clearing a significant FDA hurdle for its antiviral Galidesivir. This milestone accelerates the path toward pivotal animal studies and potential FDA approval under the Animal Rule.

Rua Bioscience's FY26 results highlight a 71% surge in customer revenue driven by international expansion, yet the company continues to face significant losses and going concern risks.