The U.S. Food and Drug Administration (FDA) does not mandate a universal sample size for sensitivity and specificity studies, but its final 2025 guidance for AI-enabled device Predetermined Change Con…
On August 5, the U.S. Food and Drug Administration (FDA) named Cadence the second participant in its TEMPO pilot program for HypertensionOS, a software device that generates protocol-bound medication-…
404 Media's weekly podcast covers Samuel Tunick, who faces prison for allegedly wiping his GrapheneOS phone before DHS officials could search it, and an AI-powered TikTok Shop scheme promoting FDA-rec…
AI-powered tools are transforming patient-reported outcomes (PROs) in clinical research by automating data collection, cleaning, standardization, and regulatory submission preparation, according to Ma…
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has weighed in on whether AI scribes are medical devices, a decision that could shape how these tools are regulated in healthcare. The…
An automated oxygen controller kept hospitalized adults in their prescribed oxygen range 85% of the time versus 63% for manual care in a randomized trial published August 3, 2026, in JAMA Internal Med…
Healthcare AI scaling faces structural barriers including data fragmentation, regulatory overhead, legacy infrastructure, and workflow gaps, according to a systems architecture analysis by an industry…
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…