Latest Fda News

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.

Atomo Diagnostics reported a 40% increase in FY26 revenue to $5.3 million, driven by a surge in HIV self-test sales and new OEM customer orders. The company is advancing its syphilis and liver test developments while enhancing manufacturing capacity.

Dimerix has strengthened its kidney disease pipeline with a US patent grant for DMX-652, extending protection until 2043 and setting the stage for a Phase 2 trial targeting acute kidney injury after cardiac surgery.

Artrya has launched its AI-powered Salix platform at Northeast Georgia Health System, marking its second U.S. commercial customer with active revenue streams from subscription and fee-per-scan models.

Cambium Bio has raised just over A$1 million through a strategic placement at a 17% premium, boosting a key shareholder’s stake as it advances its pivotal Phase 3 trial for dry eye disease.

PainChek has received a $1.123 million R&D tax incentive refund for FY2025, reinforcing its cash reserves and underpinning ongoing development of AI pain assessment algorithms and US market validation.

Noxopharm reported significant progress in its Sofra technology, highlighting enhanced cancer drug potential and preparations for a US FDA clinical trial, while managing tight cash reserves.

Optiscan Imaging has kicked off a US clinical trial with Mayo Clinic to test its InVue and InForm devices in breast conserving surgery, aiming to generate data for FDA 510(k) submissions and validate a new surgical-pathology workflow.

Radiopharm Theranostics reported robust Phase 2b results for RAD101 in brain metastases imaging, hitting 93% concordance with MRI and setting the stage for a U.S. Phase 3 trial. Meanwhile, its Phase 1 trial of RAD204 showed durable partial responses and good tolerability in advanced solid tumors.

Ceretas Limited is raising $8 million through an IPO to fund clinical trials and development of its novel therapeutic ultrasound device targeting Alzheimer’s disease symptoms.

CONNEQT Health's June quarter saw record consumer revenue growth and a 70% jump in enterprise subscription ARR, supported by a $5.5 million placement and progress on its FDA regulatory pathway for its cloud-based vascular analytics platform.