Latest Medical Devices News

EBR Systems has completed the FDA’s pre-approval inspection of its new Santa Clara manufacturing facility, receiving two Form 483 observations. The company says it expects to correct them in the fourth quarter and still anticipates approval by year-end, although the FDA has not yet made its final determination.

EMVision Medical Devices has received a $4.3 million R&D tax refund, adding non-dilutive funding as it progresses clinical work on its emu™ and First Responder devices. The cash arrives against a last reported cash balance of $17.1 million and $4.6 million in remaining grant funding at 30 June 2026.

Nexsen has paused its StrepSure clinical programme after an interim review identified performance improvements needed before a US FDA submission, pushing the target timetable back by roughly one quarter. Its shares were then suspended pending an announcement about a potentially material contract for an additional device.

ReNerve has converted regulatory approvals into its first commercial NervAlign Nerve Cuff surgeries in Hong Kong and Malaysia, expanding activity to seven jurisdictions. The milestones arrive as FY26 sales climbed 88% to $510,357 and the company builds out its US distribution network.

CMS has finalised higher Medicare inpatient reimbursement for EBR Systems’ WiSE System, lifting base payment rates by up to 93% from 1 October 2026. The change improves the commercial payment pathway, although its financial impact will depend on procedure volumes, hospital adoption and NTAP eligibility.

EMVision has completed the first stage of a Melbourne Mobile Stroke Unit study, operating its portable brain scanner in homes, ambulances and a workplace. The small, non-diagnostic feasibility study produced strong usability results while pointing to a larger clinical validation step planned for next-generation units.

EBR Systems plans to file a Changes Being Effected PMA supplement in the fourth quarter to make echo-induced pacing risks and their mitigations more prominent on WiSE System labelling. The FDA has aligned with the proposed path, but the filing and final labelling changes are still ahead.

EBR Systems’ new Santa Clara manufacturing facility has entered the FDA’s pre-approval inspection process, marking a key regulatory step for its wireless cardiac pacing business. The company continues to expect approval by the end of 2026, but the inspection does not yet amount to clearance.

The FDA has agreed that EBR Systems’ WiSE cardiac pacing system does not require a field corrective action or recall following a February cybersecurity incident. The device maker says it has found no evidence of any impact on the safety or performance of fielded systems, while remediation work continues.

OncoSil Medical has moved closer to local production after contract manufacturer Cyclotek secured ISO 13485 certification for its quality management system. Production at the Macquarie Park facility remains targeted for the end of 2Q FY27, subject to further regulatory approval.

EBR Systems has secured ISO 13485 certification for its new Santa Clara manufacturing site, paving the way for a 500% increase in WiSE System production pending FDA approval expected by year-end.

EMVision is progressing its CRC-P funded Regional Benefits Study to evaluate the emu™ bedside brain scanner in remote hospitals, aiming to speed up stroke diagnosis where CT access is limited. Site visits are complete, and protocol development is underway, with relevance extending to similar rural hospitals in the US.