Latest Healthcare Innovation News

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.

Micro-X Limited lifted revenues by 16% to $15.1 million for FY26 but posted a $9.9 million net loss, narrowing from the prior year. The company advanced key medical imaging milestones and initiated a strategic reset to sharpen commercial focus and reduce costs.

ImpediMed reported a 15% revenue increase to $14.6 million in FY26, broadened reimbursement coverage for its SOZO platform to 95% of the US population, and launched new applications in heart health and weight management.

Control Bionics has secured MHRA registration for its NeuroStrip device, unlocking commercial supply in Great Britain and launching early trials with leading UK institutions.

Recce Pharmaceuticals has secured ethics approval to add an active-controlled arm to its pivotal Phase 3 trial of RECCE® 327 Topical Gel for diabetic foot infections in Australia, enabling head-to-head comparison against existing antibiotics.

Mesoblast has treated 350 patients in its pivotal Phase 3 trial for rexlemestrocel-L, targeting chronic low back pain linked to degenerative disc disease, setting the stage for top-line results in mid-2027.

Marlin Global delivered a robust 3.1% gross portfolio return in July 2026, significantly outpacing its benchmark which fell 3.6%, thanks to strategic semiconductor underweighting and strong gains in tech giants Microsoft, Dexcom, and Amazon.

Barramundi Limited’s portfolio delivered a 2.2% gross return in July, outpacing the S&P/ASX200 hedged benchmark, driven by strong performances in healthcare and financials alongside strategic portfolio adjustments.

Zelira Therapeutics has raised nearly US$33 million into its HOPE® 1 special purpose vehicle, valuing the SPV at about US$66 million post-money. The funds will advance FDA regulatory submissions and Phase 1 clinical trials for its autism-targeting cannabinoid drug.

Patrys Limited is pushing forward with a proprietary injectable formulation of quetiapine targeting the lucrative delirium treatment market, leveraging a faster, lower-cost FDA 505(b)(2) regulatory pathway and strong patent protection.

PainChek has received a $1.123 million R&D tax incentive refund for FY2025, reinforcing its cash reserves and underpinning ongoing development of AI pain assessment algorithms and US market validation.

Optiscan Imaging has fast-tracked Stage 2 of its pioneering head and neck cancer imaging study, moving into live intraoperative imaging ahead of schedule. This advancement supports FDA regulatory efforts and enhances the company’s AI imaging development.