Latest Medical Devices News

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.

Lumos Diagnostics has increased live FebriDx sites to 215 and moved two additional top 100 US urgent care groups into network rollout across more than 40 sites. Two further health-system-owned groups are validating the test across more than 45 sites, but the announcement does not disclose contract values or guaranteed purchase volumes.

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.

PolyNovo delivered 16.1% revenue growth and a sharp improvement in operating cash flow in FY26, despite a lower statutory profit after a prior-year tax benefit and a fire-related write-off. The ASX-listed wound-care company now expects to lodge its U.S. PMA application for NovoSorb BTM before the end of 2026.

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.

OncoSil Medical has secured $5.6 million from its three largest institutional investors to fund commercial launches of its OncoSil device in the United States and Australia. The commitments follow FDA and TGA approvals and would lift pro-forma cash to $12.1 million once completed.

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.

CONNEQT Health has inked a marketing deal with US longevity platform Blueprint to boost consumer sales of its FDA-cleared Pulse arterial health monitor, targeting health-conscious Americans focused on preventative care.

Immuron Limited has inked an exclusive US distribution deal for PROIBS®, a European-certified medical device targeting abdominal discomfort, marking a key step in its digestive health portfolio growth.

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.