Latest Clinical Validation News

Resonance Health is progressing its MRI Liver Fibrosis device through late-stage clinical validation, targeting FDA biomarker qualification, while maintaining a profitable SaaMD platform and forecasting $16 million revenue for FY26.

Micro-X has captured the first human head images using its innovative carbon nanotube cone beam CT technology, marking a major technical milestone as it launches a multi-centre pilot study aimed at stroke diagnosis.

Imagion Biosystems has secured FDA clearance to proceed with its Phase 1b/2 trial of the MagSense® HER2 Imaging Agent, targeting improved detection of HER2+ breast cancer. Patient recruitment is expected to start in Q3 2026, marking a crucial step toward commercialisation.

Optiscan and Mayo Clinic have completed all key engineering milestones in their two-year partnership to develop a digital endomicroscopic imaging system for robotic surgery, extending their agreement to support further clinical and commercial planning.

4DMedical has landed a three-year commercial contract with SimonMed Imaging, deploying its CT:VQ™ technology across more than 170 US outpatient centres, marking a significant step in its US market expansion.

TruScreen Group reported a 42% increase in FY2026 sales driven by new market entries including India and Indonesia, alongside launching a large-scale cervical cancer screening program in Vietnam and submitting major UNITAID proposals.

Noxopharm has unveiled new data showing its Sofra technology dramatically boosts TLR8 activation, a key immune pathway, potentially reshaping cancer immunotherapy.

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.

4DMedical’s CT:VQ™ technology has been clinically validated in a top respiratory journal, showing a leap in patient response rates for lung volume reduction surgery from 46% to 76%, promising improved outcomes and hospital efficiencies.

Lumos Diagnostics advances US commercial rollout of FebriDx with positive reimbursement data and expanded urgent care adoption ahead of the 2027/28 flu season.