Latest Fda News

Imricor Medical Systems has achieved multiple world-first procedures using real-time MRI guidance for cardiac ablation, advancing clinical trials and regulatory progress amid a strategic commercial expansion.

Epiminder Limited has successfully listed on the ASX, raising $125 million to commercialise its FDA-approved Minder device. The company has initiated the first US implant and secured five leading medical centres for its DETECT study.

LTR Pharma has marked a key milestone with over 1,000 SPONTAN prescriptions under Australia’s Special Access Scheme and is advancing clinical trials and US market preparations for its erectile dysfunction treatments.

Tetratherix Limited (ASX, TTX) reports significant progress in clinical trials, strategic partnerships, and manufacturing capacity, positioning itself for near-term commercialisation and sustained innovation.

Following its December 2025 ASX debut and a successful IPO, Saluda Medical reports robust global revenue growth and expands its US sales force, prompting an upward revision of its FY26 revenue guidance.

Firebrick Pharma has commenced commercial manufacturing and export of its new Nasodine Throat Spray, marking a significant step in its international expansion. The company also reported a 15% increase in cash sales and reduced operating costs, signalling improving financial health.

Argenica Therapeutics has unveiled compelling AI-driven results confirming ARG-007’s significant benefits in severe acute ischemic stroke patients, setting the stage for a precision-focused Phase 2b trial.

EMVision Medical Devices reports strong progress in its emu™ Brain Scanner clinical trials, expanding recruitment across seven leading stroke hospitals and introducing new software features to enhance scan quality.

Singular Health Group has advanced its U.S. commercial footprint with the deployment of 500 new licences under its PNS contract and secured FDA clearance for its cloud-based 3DICOM MD® platform, positioning the company for significant growth.

Island Pharmaceuticals has secured key regulatory milestones for its antiviral Galidesivir, including FDA confirmation of the Animal Rule pathway and Priority Review Voucher eligibility, while strengthening US biodefense ties and expanding patent protection.

Echo IQ has completed clinical validation of its EchoSolv HF heart failure detection software with the Mayo Clinic Platform, achieving outstanding accuracy. The company has now formally submitted its FDA 510(k) clearance application, positioning itself for significant commercial expansion in the US healthcare market.

Anteris Technologies has completed a $90 million strategic investment from Medtronic as part of a $320 million capital raise, advancing its DurAVR transcatheter heart valve towards global commercialisation and pivotal clinical trials.