Latest Medical Devices News

PainChek has secured FDA De Novo clearance, enabling entry into the vast US healthcare market with a $3 billion Remote Therapeutic Monitoring opportunity. The company reports $5.6 million contracted ARR and a strong global footprint in aged care.

Mach7 Technologies reports a positive operating cash flow in Q2 FY26, securing its first customer for the new Flamingo Architecture product and advancing key strategic initiatives.

Resmed Inc. posted robust Q2 FY2026 results, with revenue climbing 11% to $1.4 billion and a 16% rise in non-GAAP earnings per share, underpinned by strong global demand and operational efficiencies.

Medical Developments International has posted positive operating cashflow for the first half of FY26, driven by robust growth in its flagship product Penthrox across Australia and Europe, alongside progress in paediatric approvals.

Control Bionics has secured a two-year US distribution agreement with AAC leader PRC-Saltillo to broaden access to its NeuroNode technology, enhancing communication options for users with complex needs.

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.

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.

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.

Cleo Diagnostics has broadened its U.S. market opportunity to around 2 million women annually and is on track to complete its pivotal clinical trial early this year, supported by a $5 million capital raise and regulatory progress.