The Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) published a Request for Information on July 16, 2026, reopening the question of whether AI d…
A consulting firm built a private benchmark of more than 1,200 FDA regulatory judgment questions and tested 18 frontier AI models, finding that every model failed the questions that carry the highest …
Hemispheric, a startup co-founded by Apple FaceID co-inventor Gidi Littwin, has raised $52 million to build a frontier AI model that decodes brain electrical activity to diagnose cognitive disorders w…
The FDA's January 2025 draft guidance on AI-enabled medical devices recommends that model descriptions detail inputs, outputs, architecture, training, and limitations, but the document remains draft a…
Explainable AI (XAI) is essential for deploying machine learning in high-stakes domains like healthcare, finance, and autonomous vehicles, where opaque models can lead to liability, non-compliance, or…
Medical Heuristic Learning (MHL), a transparent rule-based approach using large language models, aims to improve clinical decision support by combining high predictive accuracy with interpretability, …
Novo Nordisk, a Danish pharmaceutical company, struggles to measure the return on investment of generative AI due to complex, multi-step drug development processes. The company uses AI-powered digital…
The FDA released the draft MDUFA VI commitment letter for FY2028–2032, introducing structural changes to how sponsors interact with the agency, including faster pre-submission feedback, a permanent au…
The FDA cleared 14 AI/ML-enabled medical devices in Q2 2026, including De Novos and 510(k)s, spanning neurology, cardiology, radiology, and other specialties. Key clearances include neuropacs' MSAp/PS…
Utah launched the nation's first AI-powered prescription refill program in January, partnering with startup Doctronic to let a chatbot renew about 190 chronic medications, as states move to license AI…
Utah launched a prescription refill program using an AI chatbot called Doctronic, allowing residents to get refills without seeing a doctor. The program has sparked debate among doctors and experts ab…
Google Research is using AI to accelerate scientific discovery across genomics, neuroscience, epidemiology and climate science, according to Lizzie Dorfman, who leads science AI at the company. Dorfma…
Midjourney released a behind-the-scenes video of its full-body ultrasound scanner, showing the machine's hardware assembly but not providing clinical validation data. CEO David Holz said the company's…
UpDoc debuted the first FDA-cleared patient-facing clinical LLM on June 25, 2026, for insulin management in type 2 diabetes. The device, cleared via 510(k) K253281, provides voice or text insulin titr…
Researchers introduced ATHENA-R1, an AI agent trained via reinforcement learning over 212 biomedical tools to perform treatment reasoning across all FDA-approved drugs since 1939. The agent achieved 9…
A wave of bipartisan federal bills is targeting how AI companies collect and monetize personal health data, threatening the business models of digital health startups that rely on selling user data. S…
Researchers developed a provenance-aware, knowledge-graph-based multi-agent framework that integrates 466,525 Reddit posts, 60,782 WebMD reviews, and 20 years of FDA adverse event data for nine antide…
UpDoc announced on June 25, 2026, that its AI platform received FDA clearance as the first FDA-cleared clinical AI agent and LLM-enabled device, though public records show the clearance (K253281) is f…
ARPA-H is selecting teams this month to build the first FDA-authorized agentic clinical AI system, ADVOCATE, which will autonomously write prescriptions, adjust medications, and provide 24/7 cardiovas…
A study led by Harvard and Stanford researchers found that ChatGPT outperformed hundreds of physicians in diagnostic challenges, sparking concerns about AI's rapid integration into U.S. healthcare wit…