Latest Fda News

A multimillion-dollar, multiyear NIH grant will fund an expanded access program for Neurizon’s investigational NUZ-001, potentially giving up to 200 US patients access to the therapy for as long as 96 weeks. The program is designed to add long-term safety, survival and biomarker data alongside the pivotal HEALEY ALS trial.

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 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.

Arovella Therapeutics has released the first clinical batch of its off-the-shelf cell therapy ALA-101 and activated its inaugural trial site at The Alfred, setting the stage for patient dosing later this month.

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.

Cleo Diagnostics has received its first commercial batch of ovarian cancer test kits from Bio-Techne, marking the start of analytical validation critical for its FDA submission planned in early 2027.

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.

Imricor Medical Systems has reached a crucial milestone as the FDA accepts and closes the manufacturing module of its Premarket Approval submission, advancing its MR-guided electrophysiology devices closer to US market entry.

AdAlta’s partner SHcell has gained regulatory approval to provide the BZDS1901 CAR-T therapy to advanced mesothelioma patients in China’s Hainan Boao Lecheng special access zone, marking a key milestone in real-world data collection and treatment availability.

Vitrafy Life Sciences has secured its first US cell and gene therapy foothold by deploying its cryopreservation technology at Charter Medical's Innovation Hub, signalling a strategic expansion into a high-value biopharma segment.