Latest Medical Technology Innovation News

Imricor Medical Systems has taken a significant step toward US market entry by submitting its Advantage-MR EP Recorder/Stimulator system for FDA 510(k) clearance, aiming to enhance MRI-guided cardiac procedures.

Artrya Limited has begun generating fee-per-scan revenues from its Salix Coronary Plaque module at Tanner Health in the U.S., marking a key commercial milestone for the AI-powered cardiac imaging platform.

PolyNovo Limited has appointed Bruce Peatey as its new CEO, bringing extensive international healthcare experience to drive the company’s next growth phase. Peatey’s leadership is expected to accelerate PolyNovo’s expansion into new markets and outpatient care.

Artrya Limited has successfully navigated a key FDA Q-Submission meeting, receiving clear guidance on the regulatory pathway for its Salix Coronary Flow module, with a 510(k) submission planned by year-end.

EMVision Medical Devices has initiated a unique pre-hospital study in Melbourne to test its First Responder Brain Scanner within one of the world’s few Mobile Stroke Units, aiming to enhance stroke diagnosis and accelerate commercialisation.

Imricor Medical Systems has successfully completed a comprehensive Human Factors study for all its devices under FDA review, marking a critical milestone towards U.S. market entry. The extensive 7-month study involved 46 healthcare professionals and tested nine products, underscoring Imricor’s growing momentum in electrophysiology innovation.

Artrya Limited has secured FDA 510(k) clearance for its Salix Coronary Plaque module, enabling near real-time detection of high-risk coronary artery plaque and opening a lucrative U.S. market opportunity with a $950 reimbursement per scan.

Artrya Limited has secured a five-year, US$0.6 million contract with Tanner Health, marking its inaugural commercial revenue in the U.S. market for its AI-powered Salix Coronary Anatomy platform.

Artrya Limited has submitted a pivotal FDA 510(k) application for its AI-powered Salix® Coronary Plaque module, aiming for clearance in Q3 2025 and a lucrative US commercial launch.

Imricor Medical Systems has secured CE Mark approval for its NorthStar Mapping System ahead of schedule, marking a pivotal shift to software-centric MRI-guided cardiac interventions across Europe and the Middle East.

EBR Systems has completed the first commercial US implants of its FDA-approved WiSE wireless cardiac resynchronization therapy system, marking a pivotal step toward broader market adoption and reimbursement.

ImpediMed Limited has locked in a US$15 million growth capital facility with SWK Funding LLC, providing crucial financial flexibility to advance its SOZO Digital Health Platform and commercial ambitions.