Latest Fda Clearance News

CurveBeam AI reported steady device orders alongside a $4 million milestone payment from its China commercialisation deal, while progressing FDA clearance and robotic surgery system validation.

dorsaVi reports strong US commercial growth with over 100 new physical therapy sites and a 50% rise in cash receipts, alongside a strategic leadership change and breakthrough neuromorphic technology acquisition.

PainChek has secured FDA-regulated medical device status, enabling US Remote Therapeutic Monitoring reimbursement and opening a major US growth avenue. The company targets musculoskeletal pain management in non-verbal dementia patients, a largely underserved market.

Imricor Medical Systems has achieved a major milestone with FDA clearance for its NorthStar Mapping System, the first MRI-native 3D cardiac mapping platform approved in the US. This approval positions Imricor at the forefront of MRI-guided cardiac procedures in the world’s largest electrophysiology market.

Vitrafy Life Sciences has marked significant progress in Q2 FY2026 with a strategic partnership, commercial launch in North America, and advancing clinical trials, underpinning its growth in cryopreservation technology.

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.

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

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.

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.

4DMedical Limited has raised $150 million through a well-supported institutional placement to accelerate the commercialisation of its innovative lung imaging product CT – VQ™ in the US market. The capital raise comes with minimal dilution and increased insider confidence.

Imricor Medical Systems has achieved a major milestone with FDA clearance for its Vision-MR Diagnostic Catheter, paving the way for commercial sales in the US electrophysiology market.