Latest Clinical Evidence News

Saluda Medical has obtained FDA approval for its CAP24 surgical paddle lead, a first-of-its-kind device designed for closed-loop spinal cord stimulation, poised to broaden its US market reach and engage new surgical specialties.

4DMedical has cleared a major regulatory hurdle with the Therapeutic Goods Administration approving its CT:VQ™ lung imaging software, paving the way for commercial use across Australia and strengthening its global footprint.

Pacific Edge reported a $35.8 million loss in FY26 amid a 47% revenue drop following Medicare coverage loss, but a draft Medicare policy and $36.1 million capital raise set the stage for recovery.

CONNEQT Health has lodged an FDA Pre-Submission for SphygmoCor Cloud, aiming to shift its arterial health analytics from hardware to a scalable software platform with broad commercial potential.

Island Pharmaceuticals has presented encouraging Phase 2a results for its dengue antiviral ISLA-101, demonstrating safety, effective blood concentrations, and meaningful viral load reductions at the Asia Dengue Summit.

Imricor Medical Systems has submitted the third of four Premarket Approval modules to the FDA, marking a key step towards US approval of its MR-guided cardiac ablation devices.

Pacific Edge has secured NZ$36.1 million through a combination of a NZ$25.4 million placement and a significantly oversubscribed retail offer, reinforcing its strategic position to expand the Cxbladder cancer diagnostic platform.

Entropy Neurodynamics has successfully dosed all six participants in the first cohort of its Phase 2 trial for TRP-8803, an intravenous psilocin therapy targeting Binge Eating Disorder. The study demonstrated controlled psychedelic responses, setting the stage for a Data and Safety Monitoring Board review and topline results expected in July 2026.

4DMedical launches the CLEAR clinical evidence program to accelerate adoption of its CT:VQ™ imaging technology in the US acute pulmonary embolism market, aiming to expand its addressable market to US$3 billion.

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.