Latest Fda Clearance News

Epiminder has enrolled its 100th patient in the DETECT US epilepsy study ahead of schedule, while maintaining A$65.1 million in cash and no borrowings. The company says those reserves can fund clinical development and commercialisation work well into 2028.

Neurotech International has dosed the first patient in its pivotal Phase 3 trial of NTI164, with all six Australian sites now active and up to 200 children planned for enrolment. The milestone sits alongside FDA clearance and fresh funding, but quarter-end cash covered only 1.24 quarters of historical operating outflows.

Artrya has converted its largest US customer and first SAPPHIRE Study participant into a five-year commercial agreement, while delaying its planned Coronary Flow FDA submission to strengthen clinical evidence. The Salix rollout is gaining traction, but revenue remains early and scan volumes are undisclosed.

CurveBeam AI has secured its strongest first-quarter HiRise sales result, gained China regulatory clearance and raised A$7.35 million to fund the next stage of commercialisation. The progress comes alongside lower customer receipts and a reported 4.3 quarters of cash runway.

ReNerve has received supportive FDA feedback on the preclinical and testing pathway for its NervAlign Nerve Guide Matrix. The guidance sharpens the route towards a US submission, but does not amount to clearance and leaves the submission timetable open.

Mesoblast has reported a sharp commercial step-up in FY2026, with Ryoncil generating US$115.2 million in net sales and total revenue reaching US$120.3 million. The company has also completed treatment in its 350-patient back-pain trial and refinanced its debt, but remains loss-making and expects to need more capital beyond the next 12 months.

Optiscan Imaging has lodged a US FDA 510(k) application for InVue, its precision surgery device designed to provide cellular-level imaging during operations. The submission moves the technology into formal regulatory review, but clearance and commercialisation remain uncertain.

Artrya has signed a five-year agreement with Huntsville Hospital Health System, converting the first participant in its SAPPHIRE Study into a commercial customer. The deal carries a minimum contracted value of US$0.5 million for Salix Coronary Anatomy, with further usage-based revenue possible from other modules.

Optiscan Imaging has lodged a 510(k) submission for its InForm digital pathology device, moving the product from development into formal US regulatory assessment. FDA clearance is not assured, but a successful determination could open the door to commercial distribution in the company’s target market.

CONNEQT Health delivered sharp FY26 revenue growth and reduced its statutory loss as Pulse sales and clinical subscriptions expanded. But the ASX-listed medtech group ended the year with negative net assets, heavy cash burn and a material uncertainty over its ability to continue as a going concern.

Mesoblast has secured FDA approval to add a new potency assay to commercial release and stability testing for Ryoncil, its approved cell therapy for paediatric graft-versus-host disease. The regulatory decision supports tighter monitoring as manufacturing processes evolve, but the company disclosed no direct financial impact or clinical outcome data.

4DMedical delivered sharp growth in scans, sites and operating revenue as CT:VQ moved into commercial deployment across several global markets. But the company remains loss-making and its auditor issued a qualified opinion over the carrying value of goodwill and other intangible assets.