Latest Medical Devices News

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.

Orthocell has swiftly converted regulatory approval into clinical use with the first Remplir™ surgery completed in a US Department of Defense hospital, marking a key step in its US commercial expansion.

BlinkLab has secured A$17.5 million through an oversubscribed placement to fuel regulatory trials and commercial launch of its AI-driven autism and ADHD diagnostic tools.

ReNerve has moved its NervAlign Nerve Guide Matrix into stage 3 of commercial development, a key step toward FDA submission and eventual market entry. This progress supports the company’s ambition to provide surgeons with an alternative to donor nerves for repairing severe peripheral nerve injuries.

Orthocell has secured approval for its Remplir™ nerve repair device to be used across 221 U.S. military and veterans hospitals, marking a major step in its U.S. commercial expansion. The approval follows clinical validation in conflict zones, positioning Orthocell to deepen penetration into defence healthcare.

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.