Latest Medical Devices News

Imricor Medical Systems has officially launched its US commercial operations, securing Rady Children’s Hospital–San Diego as the first customer for its NorthStar iMR mapping system, following key FDA clearances including pediatric approvals.

EBR Systems has launched the WiSE Coupler in the US, a new accessory designed to improve the implantation of its wireless cardiac pacing electrode. The device has FDA clearance and was piloted in 10 procedures, marking another step in the company’s US commercial expansion.

PainChek has received a $1.123 million R&D tax incentive refund for FY2025, reinforcing its cash reserves and underpinning ongoing development of AI pain assessment algorithms and US market validation.

Ceretas Limited is raising $8 million through an IPO to fund clinical trials and development of its novel therapeutic ultrasound device targeting Alzheimer’s disease symptoms.

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.