Researchers released RegDivergence-101, a 101-pair benchmark for detecting regulatory contradictions between FDA and EMA guidance in life sciences, with an LLM judge (Claude Haiku) achieving 0.830 mac…
A law firm specializing in AI-enabled software as a medical device reports that the FDA's device classification hinges on a product's intended use and claims, not its technology, and that the 21st Cen…
Innolitics partner David Giese, who has helped bring 35+ AI-enabled diagnostic devices to the US market, published a guide on FDA Pre-Submissions, noting that the FDA currently charges no fee for Pre-…
Lila Sciences claims that three of its scientists designed a new CAR-T cancer therapy candidate in months, with preclinical results beating a leading therapy already used in patients, according to an …
A new analysis of 1,483 FDA AI/ML device records finds that follow-on 510(k) clearances for AI medical devices require dramatically fewer new patients than the original De Novo authorizations, with di…
Tentris, a high-performance, disk-based RDF graph database developed by DICE Research, claims to reduce RAM consumption from over 10 GBs to MBs and execute analytical workloads that traditionally take…
The U.S. Food and Drug Administration (FDA) is developing a plan to regulate medical devices that use generative artificial intelligence, according to Rick Abramson, director of the agency's Digital H…
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…