Latest Medical Devices News

Imricor Medical Systems has submitted its final 510(k) devices to the FDA, marking a major step towards commercialising its MRI-guided cardiac catheterisation platform in the US.

OncoSil Medical has gained Saudi FDA approval for its OncoSil™ device, enabling full reimbursement and commercial access in Saudi Arabia, the Middle East's largest healthcare market.

EMVision Medical Devices has hit key enrolment milestones in its pivotal brain scanner trial, expanded clinical endpoints, and maintained a strong cash position with $17.1 million on hand.

OncoSil Medical has completed key manufacturing validation cycles with Cyclotek, paving the way for scalable Australian production of its OncoSil™ device. With a $2.1 million capital investment, the company aims to boost margins and supply chain control ahead of commercial launch in late 2026.

ReNerve has locked in a flexible A$5 million convertible note facility with RiverFort, drawing an initial A$1.6 million to back its commercial push and US sales ramp-up.

Compumedics reported a record $60.3 million in FY26 revenue, driven by an 18% year-on-year increase and a 70% jump in SaaS recurring revenues from Somfit and Nexus 360. The company resolved supply chain disruptions and targets faster EBITDA growth in FY27.

ReNerve Limited has secured regulatory approval to market its flagship NervAlign Nerve Cuff in Indonesia, marking a major step in its Asia-Pacific expansion and unlocking access to one of the region’s largest nerve repair markets.

OncoSil Medical has submitted its Humanitarian Device Exemption application to the FDA for its OncoSil™ device targeting distal cholangiocarcinoma, entering the final review phase with a decision expected within 45 days.

OncoSil Medical secures a spot in the PALACROS consortium, advancing its OncoSil™ device through a cost-efficient Phase II trial targeting unresectable locally advanced pancreatic cancer.

Imricor Medical Systems expands its US market reach with FDA 510(k) clearances for pediatric use of its NorthStar system and Vision-MR Diagnostic Catheter, enabling radiation-free cardiac catheterisations for children.

Saluda Medical has obtained FDA approval for its CAP24 surgical paddle lead, a first-of-its-kind device designed for closed-loop spinal cord stimulation, poised to broaden its US market reach and engage new surgical specialties.

CONNEQT Health Limited is offering eligible shareholders a share purchase plan to raise up to $0.5 million at a 24.3% discount, aiming to fund its next growth phase in vascular health technology.