Latest Medical Devices News

PainChek Ltd has achieved a pivotal FDA De Novo clearance for its AI-driven Adult pain assessment app, unlocking the US market and driving its annual recurring revenue to $5.6 million. The company also launched its Infant app, targeting a vast global market of pre-verbal children.

PainChek has secured FDA De Novo clearance for its Adult App, opening immediate access to a $175 million AUD US long-term care market and advancing its Infant App commercialization targeting a $15 billion AUD global opportunity.

Mach7 Technologies reports a pivotal first quarter for FY26, marked by the initial go-live of a major U.S. Veterans Health Administration contract, leadership changes, and a strategic business reset.

Resmed Inc. kicked off fiscal 2026 with robust 9% revenue growth and a notable 290 basis points gross margin expansion, signaling strong momentum in home healthcare innovation. The company also declared a $0.60 dividend and executed a $150 million share buyback, underscoring confidence in its strategic direction.

BPH Energy’s September quarter report highlights pivotal developments across its investees, from a critical judicial review in offshore petroleum to breakthroughs in AI medical devices and clean hydrogen production.

Control Bionics reports a strong start to FY26 with nearly 10% revenue growth, expanded US reimbursement coverage, and advancing commercialization of its NeuroNode and NeuroStrip technologies.

CONNEQT Health reports robust 50% quarter-on-quarter growth in Pulse device sales and launches a new pricing strategy to boost recurring revenue. The company also secures a significant US clinical trial contract and advances cost-cutting efforts.

Cleo Diagnostics has successfully completed Stage 1 of the Medical Device Single Audit Program, marking a significant step toward FDA submission and global commercialisation of its ovarian cancer test.

OncoSil Medical reports a remarkable 917% increase in quarterly cash receipts alongside promising clinical trial results and key European market entries, signaling robust momentum in its pancreatic cancer treatment rollout.

CurveBeam AI reports a 33% increase in Q1 FY26 purchase orders, secures A$6.5 million in new funding, and finalizes a strategic joint venture for China distribution and manufacturing rights.

CurveBeam AI reports a 33% rise in device purchase orders and secures a $6.5 million placement alongside a landmark China distribution partnership. The company advances FDA regulatory milestones and establishes a vendor financing facility to boost sales.

CurveBeam AI has inked a decade-long exclusive partnership with a major Chinese medical device joint venture, unlocking rapid market entry and a $10 million capital boost to expand its weight bearing CT and AI solutions across Greater China.