Medical Device | March 12, 2026
FDA nod to LifeVac De Novo, paving for next-generation anti-choking device
The FDA classified LifeVac as a Class II medical device
The FDA classified LifeVac as a Class II medical device
The trial met its primary endpoint, with patients receiving povetacicept achieving a 52.0% reduction in UPCR at Week 36
The MAST trial is designed to test whether a single dose of pre-emptive, orally administered EBX-102-02 can protect and restore microbial diversity during transplantation
Diasens and GlucoLive are designed for diabetic, Chronic Kidney Disease (CKD), and post-transplant patients who require continuous glycaemic surveillance and integrated remote care
The Hydrus Microstent stands out as the first and only MIGS device backed by five-year clinical outcomes
The study hit its primary goal, showing a statistically significant rise in participants achieving EASI-75
The new equipment will be installed at Codis’ 400,000-square-foot Haverhill facility and is expected to be operational by 2027
The initiative provides clearer regulatory guidance and a defined path from research in space to patient access on Earth
Indomo’s ClearPen system combines a proprietary self-injection device and microneedle with a modernized triamcinolone acetonide formulation
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