Latest Fda Submission News

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.

Echo IQ has completed clinical validation of its EchoSolv HF heart failure detection software with the Mayo Clinic Platform, achieving outstanding accuracy. The company has now formally submitted its FDA 510(k) clearance application, positioning itself for significant commercial expansion in the US healthcare market.

Mesoblast has received encouraging feedback from the FDA on its cell therapy rexlemestrocel-L, showing meaningful pain relief and potential opioid use reduction in chronic low back pain patients. The company’s ongoing Phase 3 trial aims to confirm these benefits and advance regulatory approval.

Orthocell has increased its investment in Marine Biomedical to 11.7%, securing exclusive distribution rights to the innovative PearlBone™ technology as it nears FDA approval.

Cleo Diagnostics has raised $5 million to support the U.S. commercial launch of its Pre-Surgical Ovarian Cancer Test and accelerate development of a mass screening test, signaling strong investor confidence in its technology.

Echo IQ has formally lodged its FDA 510(k) submission for EchoSolv HF, an AI-driven heart failure diagnostic software validated by Mayo Clinic data, aiming to tap into a $60 billion US market.