Latest Fda Submission News

Cleo Diagnostics reports steady progress in its ovarian cancer diagnostic test development, with clinical trial recruitment on track and strategic access to major biobanks enhancing its regulatory pathway.

PainChek has completed its final FDA submission for the PainChek Adult App, targeting the US long-term care market with a potential $100 million annual opportunity. A regulatory decision is expected within 75 days, setting the stage for rapid commercialisation.

Lumos Diagnostics has inked a landmark six-year exclusive distribution agreement with PHASE Scientific for its FebriDx® rapid diagnostic test in the US, potentially unlocking nearly half a billion Australian dollars in revenue contingent on FDA approval.

Imricor Medical Systems has secured key European regulatory approvals for its second-generation NorthStar system and initiated its commercial launch, while US FDA submissions progress amid some delays.

Echo IQ has initiated a pivotal clinical validation study with the Mayo Clinic Platform to test its EchoSolv HF software, marking the final step before its planned FDA submission in late 2025.

Artrya Limited announces a strategic leadership reshuffle with co-founder John Konstantopoulos stepping into the CEO role as the company prepares for its U.S. commercial launch of the Salix® AI-powered platform.

LTR Pharma has successfully completed the extractables study for its intranasal erectile dysfunction spray SPONTAN, confirming safety compliance and initiating the next phase of leachables testing to support FDA approval.

Cleo Diagnostics has gained approval to access the prestigious PLCO biobank, a move set to strengthen its FDA submission and accelerate development of its ovarian cancer diagnostic tests.

Lumos Diagnostics has enrolled 500 patients in its FebriDx CLIA waiver clinical study, unlocking a significant milestone payment from BARDA and moving closer to FDA approval that could open a US$1 billion market.

Artrya Limited has submitted a pivotal FDA 510(k) application for its AI-powered Salix® Coronary Plaque module, aiming for clearance in Q3 2025 and a lucrative US commercial launch.

Cleo Diagnostics unveils a pioneering blood test for early ovarian cancer detection, boasting superior accuracy to existing methods and targeting a significant U.S. market opportunity.

EMVision Medical Devices has activated two additional key sites in its pivotal trial for the emu™ bedside brain scanner, advancing its path toward FDA clearance. These new sites join a growing network of leading stroke centres across the US and Australia.