Latest Medical Devices News

Optiscan Imaging Ltd has taken a significant step towards commercialising its InSpecta® veterinary imaging device in the US by submitting a regulatory dossier to the FDA. This milestone not only initiates formal review but also sets the stage for broader clinical adoption and future device approvals.

Atomo Diagnostics stands to gain significantly as Lumos Diagnostics’ FebriDx test secures FDA CLIA waiver approval, vastly expanding its US market potential. This regulatory milestone triggers substantial contracted revenues and prompts Atomo to ramp up production.

Aroa Biosurgery has completed its Symphony randomised controlled trial, demonstrating improved healing rates for diabetic foot ulcers compared to standard care. The preliminary results pave the way for clinical adoption and potential US reimbursement.

EBR Systems has implemented a one-for-ten reverse stock split of its common shares, adjusting the CHESS Depositary Interest (CDI) conversion ratio to maintain investor value. This move restructures the company’s equity without altering the overall value per CDI.

Cochlear Limited has updated its dividend details, confirming a fully franked ordinary dividend of AUD 2.15 per share for the six months ending December 2025, payable in April 2026 across multiple currencies.

Imricor Medical Systems has filed a Form 10 registration with the U.S. SEC, marking its transition to a U.S. reporting company amid ongoing FDA clearances and clinical trials. This move signals a significant step in its early commercialisation of MRI-guided cardiac ablation technology.

EBR Systems marked a pivotal transition in 2025 with FDA approval of its WiSE CRT System and the initiation of U.S. commercial implants, generating $1.6 million in revenue. Despite this progress, the company reported a net loss of $48.8 million and completed a significant capital raise to support ongoing growth.

EMVision Medical Devices has secured a $3.8 million R&D tax rebate and gained approval to claim rebates on overseas expenditures, strengthening its financial footing as it advances clinical trials for its neurodiagnostic device.

Osteopore Limited has secured non-exclusive distribution rights for an injectable regenerative bone filler across Southeast Asia, marking a strategic expansion of its orthopaedic product portfolio and opening new revenue channels.

Tetratherix Limited has raised approximately $5 million to fast-track its Tutelix prostate spacer into pivotal clinical trials across Australia and the US, aiming to improve radiation therapy for prostate cancer patients.

Orthocell has appointed LEDA Orthopaedics as the exclusive distributor for its Remplir™ nerve repair product in the UK, positioning itself for a rapid commercial launch pending regulatory approval.

Cyclopharm Limited has responded to ASX queries clarifying the material significance of its Technegas® contract with the US National Institutes of Health, while confirming robust progress in expanding its US footprint.