Latest Fda Submission News

Nexsen Limited is advancing its rapid Group B Streptococcus test, StrepSure®, with a clear FDA submission timeline and early market entries across Asia-Pacific and emerging regions.

BlinkLab has enrolled its first participant in the pivotal FDA 510(k) validation study for its autism diagnostic aid, BlinkLab Dx1, aiming for regulatory submission by the end of 2026.

Cleo Diagnostics has expanded its ovarian cancer biomarker panel from five to eight markers, enhancing test reliability and gearing up for FDA submission. A manufacturing deal is imminent, setting the stage for commercial rollout.

Artrya Limited reported a 44% increase in its half-year loss to $10.7 million as it transitioned from development to commercial operations in the US, securing FDA clearance and signing three foundation customers. An $80 million capital raise underpins its ambitious US expansion and ongoing product development.

Cleo Diagnostics reported a 53% drop in revenues and a slight increase in net loss to $1.98 million for H1 2025, while progressing its pivotal FDA clinical trial for an ovarian cancer blood test with strong regulatory and commercial milestones.

Optiscan Imaging reports a sharp 43% drop in revenue and a 43% rise in losses for H1 FY26, driven by restricted research funding in key markets. The company bolsters its balance sheet with a $17.75 million capital raise to advance clinical studies and regulatory approvals.

Lumos Diagnostics has hit a key enrollment milestone in its BARDA-funded paediatric study for FebriDx®, unlocking a US$720,000 payment and edging closer to FDA expansion.

Cleo Diagnostics has chosen Bio-Techne’s next-generation Ella™ platform to enhance its ovarian cancer blood test, aiming for faster, more precise results and a streamlined path to FDA approval.

Imricor Medical Systems has taken a significant step toward US market entry by submitting its Advantage-MR EP Recorder/Stimulator system for FDA 510(k) clearance, aiming to enhance MRI-guided cardiac procedures.

Optiscan Imaging Ltd has made significant strides in clinical studies and regulatory readiness, partnering with Australian Clinical Labs and launching new cancer imaging trials as it prepares for multiple FDA submissions in 2026.

Imagion Biosystems has completed manufacturing its MagSense® HER2 imaging agent and is preparing for a key FDA submission, while appointing a new president to lead its US operations.

Cleo Diagnostics has broadened its U.S. market opportunity to around 2 million women annually and is on track to complete its pivotal clinical trial early this year, supported by a $5 million capital raise and regulatory progress.