Latest Us Regulatory 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.

Vitrafy has added US blood network Versiti to its cryopreservation development programme, with the partnership focused on no-wash platelet preservation and regulatory verification. The deal strengthens the company’s institutional network, but initially generates no revenue and remains subject to US regulatory requirements.

Vectus Biosystems has secured a pre-IND Type B meeting with the FDA for its lead IPF drug candidate VB0004. The regulator’s written feedback, expected by mid-November, should clarify the next US development steps but does not yet authorise clinical trials.

Memphasys says it has identified a potential FDA 510(k) pathway for its Felix sperm separation system, replacing the more complex De Novo route previously contemplated. The company will seek FDA feedback before targeting a formal submission in the first quarter of 2027, while keeping commercial execution focused on existing markets.

Sonic Healthcare delivered a strong FY2026, with underlying net profit up 17% to A$621 million and dividends rising to A$1.08 per share. The next test is whether US efficiencies, LADR synergies and organic growth can offset Swiss fee cuts, a delayed UK contract ramp-up and heavier investment demands.

Nexsen has paused its StrepSure clinical programme after an interim review identified performance improvements needed before a US FDA submission, pushing the target timetable back by roughly one quarter. Its shares were then suspended pending an announcement about a potentially material contract for an additional device.

Vectus Biosystems swung to a $1.56 million FY2026 profit, but the result was driven largely by the sale of its VB4-P5 compound for XORTX shares and warrants rather than recurring operations. The company is now directing its resources towards VB0004 while its auditor flags material uncertainty over ongoing funding.

Telix’s Pixclara has become the first FDA-approved FET-PET imaging drug for glioma, opening a new US diagnostic pathway for adults and children. The approval is commercially significant, but pricing, reimbursement and launch timing remain undisclosed.

Venari Minerals says it knows of no undisclosed information behind a sharp rise in its share price and trading volume. The company points instead to ongoing Red Mountain drilling and a proposed exploration program still awaiting US regulatory approval.

Bubs Australia has secured permanent US FDA authorisation for three infant formula products, removing a regulatory barrier in the company’s largest market. The approval supports possible portfolio expansion and contract manufacturing, but the presentation contains no new earnings guidance or quantified financial benefit.

Emyria has secured a limited in-person speaking position at a US FDA hearing examining how psychedelic medicines could be delivered safely and at scale. The appearance gives the ASX-listed company a regulatory platform, but does not represent FDA approval, funding or a commercial agreement.