Proposed legislation introduced in the U.S. House of Representatives will allow AI and machine learning technology to prescribe drugs approved by the FDA autonomously. The bill, H.R.238, introduced on Jan. 7, would require amending the…
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Sujay Jadhav, Verana Health CEO
In recent years, regulatory bodies, such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have increasingly emphasized the use of real-world data (RWD) in clinical…
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Critical Security Vulnerabilities Discovered
The U.S. Food and Drug Administration has raised serious concerns about cybersecurity vulnerabilities affecting patient monitors manufactured by Chinese company Contec Medical Systems. These security flaws potentially enable cybercriminals to bypass…
Welcome to the January edition of Digital Health Digest, your trusted source for the latest in digital health and healthcare technology!In this episode, we cover major updates transforming the digital health landscape—from Bicycle Health…
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What You Should Know:
– GE HealthCare has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its updated portfolio of Voluson™ Expert Series ultrasound systems.
– The Voluson Expert 22, 20,…
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Hong Kong-based startup PanopticAI has obtained regulatory approval in the United States for its contactless pulse rate measuring application. It received the US Food and Drug Administration’s 510(k) clearance for the PanopticAI Vital Signs app…
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Breaking News: FDA’s Landmark Decision
The Food and Drug Administration (FDA) made a groundbreaking announcement on January 15, 2025, revoking the authorization of Red No. 3 in food products and ingested medications. This decisive action…
Groundbreaking AI Healthcare Regulations Unveiled
The U.S. Food and Drug Administration (FDA) has initiated a transformative step in healthcare technology by releasing comprehensive draft guidance for AI-enabled medical devices on January 6, 2025. This pioneering…
The Food and Drug Administration (FDA) published new draft guidelines aimed at improving the accuracy and performance of pulse oximeters by considering the range of skin tones.The guidance, Pulse Oximeters for Medical Purposes -…
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The U.S. Food and Drug Administration is seeking public comment on new recommendations for non-clinical and clinical performance testing to support premarket submissions for pulse oximeters for medical purposes. These include devices with a…
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