Large language models (LLMs) show considerable promise for clinical decision support (CDS) but none is currently authorized by the Food and Drug Administration (FDA) as a CDS device. We evaluated whether two popular LLMs…
Continue Reading
Tag: Food and Drug Administration
Ezra Receives FDA Clearance for Enhanced AI-Powered MRI Tech
What You Should Know:
– Ezra, a innovator in AI-driven cancer screening, today announced that its advanced Ezra Flash AI model has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
– The FDA…
Continue Reading
FDA Neuralink reviewers fired as Musk’s DOGE cuts jobs
Food and Drug Administration (FDA) staffers reviewing Elon Musk’s Neuralink were among those fired as part of widespread layoffs within the Agency.Musk is in charge of the new Department of Government Efficiency (DOGE), which…
Continue Reading
Proposed legislation paves the way for AI to prescribe drugs
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…
Continue Reading
Advancing Drug Development and Regulatory Compliance with AI-Enhanced Real-World Evidence
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…
Continue Reading
Patient Monitor Security Flaws Trigger FDA Alert
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…
Bicycle Health + $16.5m; Owlet360 Subscription for Baby Care; PanopticAI 510k; Tempus concierge app
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…
Continue Reading
GE HealthCare Unveils AI-Enhanced Voluson Expert Series Women’s Health Ultrasound
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,…
Continue Reading
Mobile pulse app in Hong Kong receives 510(k)
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…
Continue Reading
FDA Bans Red No. 3 in Food Products
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…
