Latest Clinical Evidence News

4DMedical has leapfrogged into the European lung health market by acquiring Austrian AI imaging firm contextflow, gaining immediate commercial presence and a CE-marked lung cancer screening solution.

Imugene has dosed the first patient in a new cohort combining its azer-cel CAR T therapy with BTK inhibitors, targeting patients with B-cell malignancies who failed prior BTKi treatment. This move broadens the trial’s scope and tackles a significant unmet need in blood cancer therapy.

Biome Australia has launched a multi-centre clinical trial for its proprietary probiotic BMB18, adding a prestigious Greek university to its research network and commencing recruitment within the expected timeline.

Fisher & Paykel Healthcare posted a 14% revenue increase to NZ$2.31 billion and a 24% rise in net profit to NZ$468.5 million for FY2026, driven by strong hospital product sales and ongoing innovation.

Pacific Edge reported a steep 47% revenue drop in FY26 following Medicare coverage loss but secured a draft Medicare policy covering its Cxbladder tests and raised NZ$25.4 million to fuel growth and commercial execution.

TruScreen Group Limited has kicked off a NZ$2.9 million capital raising combining a NZ$1 million placement and a NZ$1.94 million rights issue to fund its global expansion and regulatory compliance efforts. The company reported a 42% jump in product sales for FY2026 and is targeting major public health programs across 14 countries.

OncoSil Medical has clinched TGA approval for its OncoSil™ device, the first Class III medical device targeting pancreatic tumours in Australia, paving the way for local commercialisation and enhanced patient access.

Emyria has launched its first Empax clinic in Victoria on schedule, establishing a new clinical hub with trained staff and dual reimbursement pathways to support growth.

Pacific Edge edges closer to a Medicare breakthrough with a draft Local Coverage Determination proposing coverage for its Cxbladder Triage and Triage Plus tests, potentially unlocking reimbursement for over 66 million US patients.

Pacific Edge launches a NZ$6 million retail share offer at NZ$0.17 per share following a NZ$25.4 million institutional placement, aiming to strengthen its balance sheet and support Medicare reimbursement efforts for its bladder cancer diagnostics.

Pacific Edge has raised NZ$25.4 million through an oversubscribed placement priced at NZ$0.17 per share, aiming to bolster operations, support Medicare re-coverage efforts, and advance its bladder cancer diagnostic tests.

EBR Systems accelerated its U.S. commercial rollout of the WiSE CRT System in Q1 2026 with implant volumes more than doubling and revenue hitting US$2.4 million. The company also secured a key regulatory milestone in Australia with TGA Priority Review, yet losses deepened and cash burn intensified, raising fresh questions about its funding runway.