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 approval comes after a systematic review of published literature
Phase I EPRAD study of DT-9081 demonstrated a favorable safety profile
The study hit its primary goal, showing a statistically significant rise in participants achieving EASI-75
The Hydrus Microstent stands out as the first and only MIGS device backed by five-year clinical outcomes
Giredestrant shows promise despite missing primary goal
The agreement brings to market a method pioneered at CU Boulder that enables the reliable synthesis of long RNA strands
Enhertu recently received Breakthrough Therapy Designation, accelerating development and review for this critical patient population
The new equipment will be installed at Codis’ 400,000-square-foot Haverhill facility and is expected to be operational by 2027
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