Latest Healthcare News

PainChek Limited has confirmed FDA De Novo classification for its PainChek Adult App, promptly disclosing the material regulatory milestone to the ASX and signalling a significant step towards US market entry.

Health Canada has requested additional information, extending its review of CLINUVEL’s SCENESSE® for erythropoietic protoporphyria (EPP) into 2026. Meanwhile, Canadian patients continue to access the treatment via a Special Access Program.

PolyNovo Limited has appointed Bruce Peatey as its new CEO, bringing extensive international healthcare experience to drive the company’s next growth phase. Peatey’s leadership is expected to accelerate PolyNovo’s expansion into new markets and outpatient care.

Anteris Technologies has secured its first European regulatory clearance to commence the global PARADIGM Trial for its DurAVR Transcatheter Heart Valve, marking a significant step toward worldwide commercialization.

Clarity Pharmaceuticals has inked a pivotal supply agreement with Nusano to ensure a steady source of copper-67, a critical isotope for its upcoming Phase III prostate cancer trial and future commercialisation plans.

TrivarX Limited has resumed trading on the ASX following the announcement of a significant acquisition and a fresh capital raising, signaling a pivotal moment for the biotech company.

TrivarX Limited has announced the acquisition of Stabl-Im, a novel stable isotope MRI technology for early brain tumor detection, backed by a $4.2 million capital raise including investment from biotech leader Dr Daniel Tillett.

Aroa Biosurgery delivered a robust September quarter with strong cash flow and record sales of its Myriad product, while reaffirming its FY26 revenue and EBITDA guidance. The company also highlighted a promising US Medicare reimbursement proposal for its Symphony product.

Cogstate Limited reports a record-breaking quarter with sales contracts soaring 88% year-on-year, driven by expanding markets and new therapeutic areas. The company signals continued investment in growth initiatives, including AI and Asia-Pacific expansion, while projecting a strong first half of FY26.

EMVision Medical Devices’ latest Share Purchase Plan has attracted applications exceeding its initial $1 million target, with limited oversubscription capacity remaining ahead of the October 23 closing date.

EVE Health Group Limited has launched a $1.1 million capital raising via a placement to fund the commercial rollout of its two pharmaceutical products, Dyspro and Libbo. The offer includes shares and options, with some subject to shareholder approval.

Vectus Biosystems has temporarily paused trading of its securities pending a forthcoming announcement, signaling potential material news for investors.