Latest Fda Clearance News

Imagion Biosystems has raised $3.75 million to fund the start of its Phase 1b/2 clinical trial for the MagSense HER2 imaging agent in the US, following FDA clearance. The capital raising involves a two-tranche share placement with free attaching options, led by CPS Capital.

Echo IQ has locked in a binding Heads of Agreement with Pro Medicus for a strategic A$20 million investment and a US commercial partnership to accelerate adoption of its AI-powered cardiac diagnostic platform.

AFT Pharmaceuticals surged 22% to NZ$254.7 million revenue in FY26, surpassing profit guidance and securing FDA approval to advance a pivotal injectable iron Phase III trial targeting a $7.4 billion market. The company is poised for further global expansion and product launches in FY27.

CONNEQT Health has lodged an FDA Pre-Submission for SphygmoCor Cloud, aiming to shift its arterial health analytics from hardware to a scalable software platform with broad commercial potential.

Echo IQ has partnered with Mayo Clinic to assess its AI platform's ability to predict heart failure risk in patients undergoing cancer therapy, targeting the growing cardio-oncology sector.

Imricor Medical Systems has submitted the third of four Premarket Approval modules to the FDA, marking a key step towards US approval of its MR-guided cardiac ablation devices.

Imagion Biosystems has secured FDA clearance to proceed with its Phase 1b/2 trial of the MagSense® HER2 Imaging Agent, targeting improved detection of HER2+ breast cancer. Patient recruitment is expected to start in Q3 2026, marking a crucial step toward commercialisation.

4DMedical has leapfrogged into the European lung health market by acquiring Austrian AI imaging firm contextflow, gaining immediate commercial presence and a CE-marked lung cancer screening solution.

4DMedical has landed a three-year commercial contract with SimonMed Imaging, deploying its CT:VQ™ technology across more than 170 US outpatient centres, marking a significant step in its US market expansion.

Immuron Limited has responded to an ASX price query following a sharp rise in its share price and trading volume, confirming no undisclosed information but pointing to a recent CEO presentation as a possible driver.

Tetratherix Limited secures $15 million via institutional placement plus a capped $2 million share purchase plan at a 14% discount, aiming to fast-track manufacturing expansion and commercial partnerships.

PainChek has secured A$5.5 million via convertible notes to accelerate its US sales expansion and strengthen working capital amid key commercial milestones.