Latest Market Access News

Atomo Diagnostics capitalises on Lumos Diagnostics’ FebriDx FDA CLIA waiver with over $2 million in new sales orders and a $3 million capital raise, expanding its global footprint and product pipeline.

Elsight’s Halo connectivity platform has gained critical approval on the U.S. Department of War’s DCMA Blue List, enabling rapid military procurement amid a historic US$75 billion drone budget surge.

Nexsen Limited has cleared a major FDA regulatory hurdle for its StrepSure rapid Group B Streptococcus test, confirmed a clear 510(k) submission pathway, and secured over A$1.7 million in non-dilutive grants to expand clinical validation and market rollout in Asia-Pacific and neonatal diagnostics.

OncoSil Medical reported a 60% year-on-year increase in dose sales in Q3 FY26, boosted by expanding treatment centres and advancing clinical trials, while cost-cutting and a new manufacturing facility aim to underpin growth.

Proteomics International is pivoting from research to disciplined commercial execution of its proteomics-based diagnostic tests, focusing on distributor partnerships and reimbursement pathways in Australia and the US.

Streamplay Studio delivers a fourth consecutive quarter of positive cash flow, underpinned by steady publishing revenues and strategic platform growth in new regions.

Algorae Pharmaceuticals has struck an exclusive commercial and licensing agreement with global pharma Zydus Lifesciences to bring 10 injectable, oral, and specialty medicines to Australia and New Zealand, pending regulatory approvals.

Imricor Medical Systems advanced FDA clearances and expanded clinical trials in Q1 CY26, positioning for commercial growth despite higher operating cash outflows.

Vitrafy Life Sciences completed Phase II of its U.S. Military platelet cryopreservation study with strong results for a simplified no-wash process, accelerating commercial interest and progressing FDA device registration despite manufacturing delays.

American Tungsten & Antimony (ASX: AT4) has set up a Level 1 ADR program with Deutsche Bank, paving the way for its planned Nasdaq listing in Q2 2026 and opening U.S. dollar trading access for American investors.

EVE Health Group has appointed Ben Rohr as CEO, shifting Damian Wood to focus on regulatory and clinical affairs, aiming to sharpen commercial execution amid ongoing product rollouts.

TruScreen Group has met its FY2026 revenue guidance with a 41% jump in product sales, while investing heavily in new markets and pursuing a major UNITAID funding bid that could reshape its medium-term outlook.