Latest Regulatory Submissions News

Echo IQ reports a remarkable 153% increase in echocardiogram processing through its EchoSolv AS platform in the US, with a Mayo Clinic validation study nearing completion ahead of a critical FDA submission. The company is also advancing European market entry and strengthening its advisory team to accelerate global growth.

Micro-X has completed its first Head CT test bench, marking a key milestone as it begins pivotal imaging trials in Australian hospitals to revolutionize stroke diagnosis.

Anteris Technologies has gained shareholder approval for an ASX waiver allowing flexible capital raising and updated its PARADIGM trial timeline, now set to begin patient enrolment in Q4 2025 after addressing FDA requests.

EMVision Medical Devices launches a $2 million Share Purchase Plan offering shares at a 16.4% discount, bundled with free options exercisable at $3.40, aiming to bolster clinical and commercial milestones.

EMVision Medical Devices has initiated a unique pre-hospital study in Melbourne to test its First Responder Brain Scanner within one of the world’s few Mobile Stroke Units, aiming to enhance stroke diagnosis and accelerate commercialisation.

Micro-X Ltd has secured a $4.4 million Australian Government grant to develop and trial a portable Head CT scanner designed for standard ambulances, aiming to transform emergency stroke care with faster diagnosis and treatment.

Neurizon Therapeutics has locked in a significant R&D tax incentive advance covering overseas and domestic development costs for its lead ALS drug candidate NUZ-001, accelerating its clinical progress with a $5.6 million rebate expected in 2025.

Orthocell’s nerve repair device Remplir is being adopted in Australia for nerve-sparing prostate cancer surgeries, aiming to reduce erectile dysfunction and urinary incontinence post-operation. This development could significantly expand Remplir’s market reach globally.

Imagion Biosystems has reached key milestones in its MagSense® HER2 breast cancer imaging program, including starting manufacturing for its Phase 2 trial and launching an AI imaging protocol collaboration with Wayne State University.

Orthocell Limited reports an 81.1% overall treatment success rate from its Remplir Real World Evidence study, reinforcing the product’s safety and efficacy as it expands sales in the US and prepares regulatory submissions for the EU and UK.

Cambium Bio has secured a strategic partnership with French pharmaceutical leader Benta SAS to commercialise its regenerative dry eye treatment, Elate Ocular, across Europe and the Middle East. This follows a second platelet-lysate licensing deal within days, underscoring growing industry confidence in Cambium’s platform.

Lumos Diagnostics, backed by BARDA, is set to begin a pivotal pediatric clinical study to extend the use of its rapid respiratory infection test, FebriDx, to children aged 2–12 in U.S. CLIA-waived settings, potentially unlocking a $1 billion market.