Latest Fda News

EMVision Medical Devices has commenced the pivotal clinical trial for its emu™ bedside brain scanner aimed at FDA clearance, while advancing its First Responder device through successful aeromedical testing and ethics approvals. The company maintains strong cash reserves of $12.58 million to support ongoing innovation and clinical activities.

Universal Biosensors reported a 28% increase in customer receipts to $1.6 million for Q1 2025, alongside improved cash flow and plans for a new product launch later this year.

Zelira Therapeutics has enhanced its financial flexibility through a $1.15 million R&D tax refund and a $1 million At-the-Market equity facility, while progressing FDA trial preparations for its HOPE® 1 autism treatment.

4DMedical Limited reports a 103% surge in year-to-date revenue, secures major contracts with leading healthcare providers, and advances its CT:VQ™ technology towards FDA clearance.

ReNerve Limited reported a 39% sales increase in Q3 FY25 alongside compelling clinical validation of its NervAlign® Nerve Cuff and strategic international partnerships, positioning the company for broader market penetration.

IDT Australia reports a robust 30% jump in quarterly revenue to $4.1 million, driven by strong contract wins and a $62 million pipeline of open proposals, signaling sustained growth in pharmaceutical manufacturing.

Echo IQ Limited marked a pivotal quarter with FDA clearance for EchoSolv AS, strategic US partnerships, and a clear path toward reimbursement and broader commercialisation.

Nova Eye Medical reported a 27% rise in Q3FY25 sales excluding China, driven by record US performance and a sharp reduction in glaucoma segment losses. The company confirmed FY25 revenue guidance and unveiled plans to expand its iTrack™ technology into ocular drug delivery.

LTR Pharma reports strong Q1 2025 progress with FDA pre-IND meeting success, scientific acclaim for SPONTAN’s rapid absorption, and strategic launch of ROXUS to fast-track US market entry.

Lumos Diagnostics reported a 21% quarter-on-quarter revenue increase in Q3 FY25, driven by strong product sales and expanded development agreements. The company also secured Medicare coverage in key US regions and advanced its pivotal FebriDx CLIA waiver study with FDA submission expected by year-end.

Nyrada Inc. posted a significant $2.46 million loss for H1 FY25, driven by increased R&D spend, while advancing its lead drug NYR-BI03 into first-in-human trials following regulatory approval.

Zelira Therapeutics has received a $1.15 million cash refund from the Australian Government’s R&D Tax Incentive Scheme, bolstering its working capital to advance clinical development and business operations.