Velmeni received FDA 510(k) clearance for VELMENI for DENTISTS 3D, AI-assisted software that segments anatomy and reconstructs views from cone-beam computed tomography scans. The clearance gives CEO M…
The U.S. Food and Drug Administration (FDA) has built ELSA, a generative AI platform available to all 16,000 staff, and Halo, a governed data foundation on Databricks, achieving 85% daily staff adopti…
A Nature Medicine study published June 12, 2026, found that general-purpose frontier chatbots—OpenAI's GPT-5.2, Google's Gemini 3.1 Pro, and Anthropic's Claude Opus 4.6—outperformed specialist clinica…
Medtronic PLC unveiled Touch Surgery Aide, an AI-powered compute platform for the operating room that runs on NVIDIA's accelerated computing infrastructure, enabling real-time multimodal AI support du…
The FDA named Dexcom the first participant in its TEMPO pilot on July 22, 2026, pairing real-world evidence collection with CMS's ACCESS payment model to support wearable diagnostic AI. Dexcom's devic…
Utah's program allowing an AI chatbot to renew prescriptions has produced surprising results after six months of data, testing doctors, regulators and the FDA, according to physician Jesse Pines in Fo…
A developer with 18 months of experience integrating AI into a quality management system (QMS) reports that AI's real value is operational and limited, not the panacea vendors imply. Reliable uses inc…
Paris-based Raidium launched its AI-native radiology platform Raidium Read at Moffitt Cancer Center, replacing legacy radiomics tools for clinical trials and research. The platform, built around Raidi…
The U.S. Food and Drug Administration (FDA) has introduced Predetermined Change Control Plans (PCCPs) as a regulatory tool allowing companies to pre-clear certain device changes within a 510(k), De No…
FDA issued a warning letter to Nihon Kohden Digital Health Solutions on July 14, 2026, rejecting the company's decision to document a software update as a letter to file instead of submitting a new 51…
Researchers have developed LLM-T1D, an interpretable insulin pump controller that combines reinforcement learning with large language models to achieve 73.5% Time in Range blood sugar control on the F…
AI and real-world evidence (RWE) are accelerating rare disease treatment by extracting data from electronic health records and other sources, compressing traditional clinical trial timelines. The FDA …
AI and real-world evidence (RWE) are converging to accelerate evidence generation for rare disease therapies, addressing the paradox where patients with the greatest need face the longest waits. By co…
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…