Latest Medical Devices News

CurveBeam AI reported steady progress in Q2 FY26 with five new device purchase orders, a $4 million milestone payment pending receipt, and key regulatory submissions underway in the US and China.

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.

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.

Compumedics has landed a $4.2 million order for its advanced MEG system from Shandong Normal University, pushing total contracted MEG sales to around $30 million and extending revenue visibility into FY27.

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.

Control Bionics has raised $3.8 million to fuel growth, forged a key distribution deal with Tobii, and integrated with Apple’s BCI protocol, while advancing its NeuroStrip and NeuroBounce platforms.

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.

EMVision Medical Devices reports strong clinical trial progress for its portable brain scanners, backed by solid cash reserves and milestone grant funding.

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.

Control Bionics has partnered with Tobii Dynavox to pilot its NeuroNode technology across five US states, aiming to enhance communication access for users of augmentative devices.