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.

Nexsen Limited's subsidiary has won a HK$6 million grant to accelerate clinical validation and manufacturing of its rapid Group B Streptococcus diagnostic in Hong Kong, positioning the city as a key Asia-Pacific hub.

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.

BlinkLab has enrolled its first participant in the pivotal FDA 510(k) validation study for its autism diagnostic aid, BlinkLab Dx1, aiming for regulatory submission by the end of 2026.

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.

Resonance Health has received a $732,851 refund from the Australian Taxation Office, reflecting its FY2025 R&D tax incentive claim net of income tax payable. This cash inflow strengthens the company’s financial position ahead of its March quarterly report.

BlinkLab has completed onboarding its tenth and final clinical site for its pivotal FDA 510(k) trial of an AI-powered autism diagnostic aid, setting the stage for patient enrolment to begin this month.

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.