Google's Pixel Watch 5, priced at $399.99, offers improved GPS and new software features like Wear OS 7 and offline Gemini, but its most anticipated health features—blood pressure and insulin resistan…
A JAMA viewpoint argues that autonomous AI will outperform every doctor-AI team, citing automation bias and human latency as the weak link once model performance exceeds a threshold. The authors conce…
A new analysis by Innolitics of 890 FDA clearance letters for AI/ML software-as-a-medical-device authorizations through August 2026 finds that 57 percent name an in-house regulatory or quality person,…
A new multi-agent system, GxP-Agent, achieved 100% structural match on the FDA pilot submission CDISCPilot01 (254 subjects, 49 ADSL variables) across three runs, compared to 59.2% for the best retriev…
Happy Health, a startup founded by Dustin Freckleton after he suffered a stroke at 24, emerged from stealth on Tuesday with $75 million in funding from ARCH Venture Partners and OpenLoop to build an A…
The U.S. Food and Drug Administration (FDA) released a discussion paper on August 18, 2026, outlining potential regulatory approaches for generative AI-enabled medical devices, with comments due Octob…
ASX-listed healthcare companies are building competitive moats in AI by combining proprietary algorithms with regulatory expertise, specialist knowledge, and workflow integration, according to experts…
The FDA's Predetermined Change Control Plan (PCCP) lacks a requirement that machine-generated signals teaching medical AI systems be tied to real clinical performance, according to a new analysis. A M…
A Perspective in Nature Reviews Drug Discovery finds that despite a decade of intense interest, AI in drug discovery has shown disappointingly limited clinically relevant impact, with no evidence yet …
On February 2, 2026, the FDA's Quality System Regulation was replaced by the Quality Management System Regulation, incorporating ISO 13485:2016 by reference, and removing the legacy 820.180(c) exempti…
The EU AI Act, adopted in 2024, introduces risk-tiered regulation with fines up to €35 million or 7% of global turnover for non-compliance, while NIST's AI RMF provides a voluntary but influential fra…
The FDA advisory committee's vote against Capricor Therapeutics' cell therapy for Duchenne muscular dystrophy highlights a broader challenge: precision medicine shrinks patient populations, making tra…
A survey of 215 members of the Society of Breast Imaging found that about half already use FDA-approved AI tools for breast cancer detection, but only 35 percent report lower recall rates, compared wi…
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…