Latest Fda News

dorsaVi has unveiled Sensor v6.5, its first wearable sensor that processes and acts on movement data in real time without cloud reliance, marking a key milestone in wearable Physical AI technology.

ImpediMed reported a 3% revenue increase to $3.6 million in Q4 FY26, bolstered by a $15.3 million capital raise and strategic leadership hires as it pushes growth in cancer survivorship, heart health, and weight management.

Argent BioPharma has eliminated US$5.5 million in secured debt through a global licensing agreement for its CannEpil® epilepsy therapy, while completing a key acquisition and advancing clinical trials in veterinary therapeutics.

Lumos Diagnostics reported a 6% revenue increase to US$13.2 million for FY26, driven by an 875% surge in FebriDx® sales following a pivotal CLIA waiver. The company expanded U.S. adoption to 170+ healthcare sites and secured milestone payments exceeding US$6 million.

Echo IQ has locked in a strategic $20 million investment and US partnership with Pro Medicus, alongside a $110 million capital raise, positioning the company for accelerated commercial expansion of its AI-driven cardiovascular diagnostics in the US.

Syntara secured positive FDA feedback for its Phase 2b amsulostat trial in myelofibrosis and raised $8 million to extend its cash runway to Q3 2027, while preliminary data showed promising brain inflammation reduction in a Parkinson’s-related disorder.

BlinkLab has bolstered its war chest with a A$17.5 million placement, secured a foundational US patent valid through 2041, and made significant progress in its FDA autism diagnostic trial and European ADHD study.

Imricor Medical Systems has officially launched its US commercial operations, securing Rady Children’s Hospital–San Diego as the first customer for its NorthStar iMR mapping system, following key FDA clearances including pediatric approvals.

Adherium reports a near tenfold surge in recurring revenue from remote patient monitoring and clinical evidence supporting significant cost reductions in respiratory care.

Patrys Limited is pushing forward with a proprietary injectable formulation of quetiapine targeting the lucrative delirium treatment market, leveraging a faster, lower-cost FDA 505(b)(2) regulatory pathway and strong patent protection.

EBR Systems has launched the WiSE Coupler in the US, a new accessory designed to improve the implantation of its wireless cardiac pacing electrode. The device has FDA clearance and was piloted in 10 procedures, marking another step in the company’s US commercial expansion.

Argenica Therapeutics is gearing up for a pivotal late-stage clinical trial of its neuroprotective drug ARG-007 (xaranetide) in acute ischaemic stroke, backed by strong safety assays and solid funding.