Leica Biosystems announced FDA clearance on August 11, 2026 for Aperio iQC DX, the industry's first standalone AI quality control software for digital pathology, which detects up to 24% more slide-scan artifacts than manual review.
The FDA cleared Artera's ArteraAI Breast on May 6, 2026, the first digital pathology-based AI risk stratification tool for HR+/HER2-negative breast cancer, delivering same-day metastasis risk scores from existing biopsy slides.
The FDA cleared UpDoc V1.0 on December 23, 2025, the first Software as a Medical Device built around a patient-facing large language model, for managing insulin dosing in adults with type 2 diabetes.
A federal judge has ordered UnitedHealth to turn over internal documents about its nH Predict AI tool, which plaintiffs say denies Medicare Advantage extended-care claims that are reversed on appeal roughly 90 percent of the time.
Kintsugi Voice analyzes subtle acoustic patterns in short speech samples to screen for depression, part of a growing body of research into vocal biomarkers for mental health.
AI-Stroke's smartphone screening tool detected twice as many true stroke cases as standard paramedic checklists in a study of 2,000 emergency staff.
Pennsylvania's lawsuit against Character.AI over chatbots posing as licensed medical professionals could reshape how AI companion apps are allowed to talk about health.
A Swedish AI model that predicts molecular behavior in a fraction of the usual computing time could compress the costliest early stage of drug discovery.
UpDoc's FDA clearance for a patient-facing LLM medical device marks a regulatory first—and a test case for how far conversational AI can go in clinical care.
At WWDC 2026 Apple redesigned its Health app and rebuilt its heart-rate engine, but delayed Project Mulberry, its rumored AI health coach, saying it wanted more reliable biometric data first, even as Google's Gemini Health Coach already shipped in May.