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 approval comes after a systematic review of published literature
Phase I EPRAD study of DT-9081 demonstrated a favorable safety profile
Doctors recommended a robotic Strassmann Metroplasty, a reconstructive surgery that joins the two halves of the uterus into a single cavity capable of supporting pregnancy
Huwel’s diagnostic solutions leverage open RT-PCR system
The initiative provides clearer regulatory guidance and a defined path from research in space to patient access on Earth
The document, published under the Accelerating Clinical Trials in the EU (ACT EU) initiative, sets out how trials should be conducted when health emergencies disrupt normal research operations
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