Browsing: FDA

Share on PinterestAn FDA panel has called for an easing of restrictions on testosterone replacement therapy (TRT). Image Credit: Malorny/Getty…

Listen to the article 2 min This audio is auto-generated. Please let us know if you have feedback. Dive Brief:…

Clearance Expands vMap’s Non-Invasive Mapping Capabilities with Direct ECG Data Streaming, Software-Only Deployment and 3D Model Import Tools SAN DIEGO–(BUSINESS…

The Food and Drug Administration received more than 100 comments after seeking responses on how to monitor the real-world performance…

The Food and Drug Administration lacks adequate staffing to oversee medical device recalls, according to a report released Friday by…

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What You Should Know:  – Ceribell, Inc. has secured FDA 510(k) clearance for the world’s first continuous, AI-powered delirium monitoring…

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Dive Brief: The Food and Drug Administration has created a pathway for unauthorized digital health devices to access a new…

What You Should Know:  – PathAI has secured a historic regulatory milestone with the FDA qualification of its AIM-MASH AI…