Latest Fda Clearance News

PainChek grew recurring revenue, implemented licences and customer sites in FY2026, but its $8.94 million loss and $9.24 million operating cash outflow prompted an explicit going-concern warning from its auditor. The company is now betting that US deployments and a sharper commercial focus can convert market access into cash-generating growth.

Echo IQ says it sees a path to US FDA clearance for EchoSolv HF after receiving a Not Substantially Equivalent determination. The company is weighing an appeal, an Ombudsman review or a fresh 510(k) submission, but has not selected a route or set a firm timetable.

CurveBeam AI has secured FDA 510(k) clearance for CT-based bone mineral density measurement, establishing the first regulatory step towards a potential new SaaS offering. The more commercially significant HiRise weight-bearing application still requires a separate clearance.

Artrya has launched its AI-powered Salix® platform commercially in the US, securing three foundation health systems and raising $80 million to fuel growth. With FDA clearance for its Coronary Plaque module and a pivotal clinical study underway, the company is poised for scaling revenues amid a strong balance sheet.

Singular Health Group lifted revenues over fivefold to $1.43 million in FY26, driven by US commercial rollouts of its 3DICOM platform, but posted a $6.34 million loss. The company strengthened its US foothold with FDA clearance and a controlling stake in an associate.

4DMedical’s CT:VQ™ lung imaging technology secured FDA clearance and CMS reimbursement, driving rapid adoption in top US medical centres and expanding its addressable market to $3 billion with new clinical programs and European contracts.

Imricor Medical Systems and Philips have launched a combined interventional MR lab solution integrating Philips’ 1.5T BlueSeal MRI with Imricor’s MR-compatible systems, targeting cardiac electrophysiology and setting a new standard for MR-guided interventions.

Imagion Biosystems has signed key CRO work orders and completed manufacturing of its MagSense HER2 Imaging Agent, advancing its Phase 1b/2 clinical trial targeting HER2+ breast cancer. Trial initiation is underway with seven prospective sites, including contract talks with the first US clinical site.

Epiminder Limited reported a $42.7 million loss for FY26, driven by clinical trial and product development costs following a $125 million IPO. The company progresses its FDA-approved Minder implantable EEG monitor with a pivotal US trial and next-gen device on track for 2028 launch.

EMVision Medical Devices has made significant strides in its emu™ bedside scanner pivotal trial and First Responder program, boosting FY26 revenue by 57% while trimming its net loss by 15%.

Artrya Limited marked its first full year of US commercial operations with a $25.18 million loss, driven by regulatory clearances, customer contracts, and an $80 million capital raise.

ImpediMed has secured FDA 510(k) clearance for its SOZO Digital Health Platform to assess sarcopenia risk, marking it as the only FDA-cleared bioimpedance spectroscopy solution for this clinical application. This clearance enables clinicians to non-invasively monitor muscle loss in cancer and chronic disease patients, potentially improving treatment outcomes.