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News about "De Novo clearance"
Ultrasound AI Secures FDA De Novo Clearance for Delivery Date AI Technology
FDA grants De Novo clearance to cloud-based Delivery Date AI, enabling real-time predicted delivery dates from standard ultrasound images to support clinical decisions in pregnancies with uncertain dating.
De Novo Clearance | 03/03/2026 | By News Bureau | 453
Bridge to Life Secures FDA De Novo Clearance for VitaSmart HOPE System in Liver Transplantation
Bridge to Life has received FDA De Novo clearance for its VitaSmart HOPE System, creating a new regulatory pathway for hypothermic oxygenated perfusion in US liver transplantation.
De Novo Clearance | 21/01/2026 | By News Bureau | 247
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