Latest Medical Devices News

Anteris Technologies has gained U.S. Medicare reimbursement eligibility for its pivotal PARADIGM Trial, clearing a key hurdle for clinical site activation and accelerating its transcatheter heart valve study.

OncoSil Medical reported a 60% year-on-year increase in dose sales in Q3 FY26, boosted by expanding treatment centres and advancing clinical trials, while cost-cutting and a new manufacturing facility aim to underpin growth.

Imricor Medical Systems advanced FDA clearances and expanded clinical trials in Q1 CY26, positioning for commercial growth despite higher operating cash outflows.

TruScreen Group has met its FY2026 revenue guidance with a 41% jump in product sales, while investing heavily in new markets and pursuing a major UNITAID funding bid that could reshape its medium-term outlook.

Imricor Medical Systems updates its SEC Form 10 with minor SEC-driven revisions as it pushes forward with FDA clearances and clinical trials, reporting a $25.3 million net loss in 2025 amid early-stage commercialisation.

EBR Systems secures Priority Review from Australia's TGA for its wireless cardiac pacing system, fast-tracking regulatory approval and expanding access for heart failure patients. This follows strong US commercial momentum after FDA approval.

Compumedics maintains robust sales momentum but faces FY26 revenue timing challenges due to MEG installation delays and a cautious Somfit D rollout. The company expects solid year-on-year growth and positions for improved execution in FY27.

Orthocell’s Q1 FY26 revenue hits $3.2 million, buoyed by growing US sales of its Remplir nerve repair device and a robust $48 million cash position supporting global expansion.

AVITA Medical’s Cohealyx-I study interim results show a significant acceleration in skin grafting time for full-thickness wounds, reducing mean time to graft from 33.2 to 13.6 days. The ongoing trial’s promising data could reshape wound care protocols.

EMVision Medical Devices has ramped up recruitment in its pivotal FDA trial across eight hospitals and is nearing results from multiple pre-hospital studies, all while bolstering its cash position with a $3.8 million R&D tax refund and $6.6 million in grant funding.

EBR Systems has reported a significant increase in commercial implantations of its WiSE System in Q1 2026, more than doubling case volumes from the previous quarter and projecting preliminary revenue between US$2.25 million and US$2.36 million.

Imricor Medical Systems has submitted its NorthStar Mapping System for FDA pediatric label expansion, aiming to accelerate adoption in over 250 US children’s hospitals and broaden its commercial footprint.