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News about "De Novo Classification "
U.S. Food and Drug Administration grants De Novo clearance to LifeVac, classifying it as a Class II medical device for use as a second-line treatment in choking emergencies.
De Novo Classification | 09/03/2026 | By News Bureau | 168
Biolinq Secures FDA De Novo Classification for Wearable Glucose Sensor
San Diego-based health tech startup Biolinq Incorporated has announced that the US Food and Drug Administration (FDA) has granted De Novo Classification for its lead product, Biolinq Shine, a fully autonomous, needle-free glucose sensor.
De Novo Classification | 29/09/2025 | By Dineshwori | 344
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