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FDA’s List of Authorized AI Medical Devices Tops 1,600, Revealing the Scale of a Quiet Boom
The FDA has now authorized more than 1,600 AI-enabled medical devices, with 181 clearances in just the first half of 2026, underscoring how deeply machine learning has embedded itself into everyday clinical practice even as the agency says its public list is not fully comprehensive.
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TytoCare Wins FDA De Novo Clearance for First AI Tool That Reads Eardrum Images
The FDA has granted TytoCare a De Novo classification for an AI system that analyzes otoscope video to flag eardrum bulging, creating an entirely new device category for AI-powered ear, nose and throat image analysis.
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Bayer Partners With Iambic Therapeutics to Hunt for Hard-to-Drug Targets With AI
Bayer has signed a small-molecule drug discovery partnership with AI startup Iambic Therapeutics, leaning on its Enchant and NeuralPLexer models to go after disease targets that have long resisted conventional chemistry.
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Samsung Teases AI-Powered Health Companion for the Galaxy Watch, Betting on Always-On Coaching
Samsung has previewed a new AI-powered health companion feature for its Galaxy Watch line, joining Meta, Oura and a wave of consumer wearable makers racing to turn years of sensor data into personalized, always-on health coaching.
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AstraZeneca Bets $1.86 Billion on Insitro’s AI Drug Discovery Platform
AstraZeneca has signed a $1.86 billion partnership with AI drug discovery startup Insitro, the latest in a wave of pharma-AI deals that have topped $47 billion in six months even as no AI-designed drug has yet won FDA approval.
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Mayo Clinic AI Model Spots Pancreatic Cancer 16 Months Before Clinical Diagnosis in Validation Study
A Mayo Clinic-developed AI system detected signs of pancreatic cancer in nearly three out of four cases roughly 16 months before clinical diagnosis in a validation study published in Gut, and is now moving into prospective testing.
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UK’s GEMINI Study Shows AI Boosts Breast Cancer Detection by 10.4%, Cuts Wait Times to Three Days
A prospective UK study published in Nature Cancer found AI-assisted breast cancer screening increased detection rates by 10.4% and reduced the time to notify patients of results from roughly 14 days to just three.
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Swedish Trial Finds AI Can Flag Breast Cancer Signs Up to Six Years Before Diagnosis
A large Swedish study published in Radiology tested three commercial AI systems on nearly 89,000 mammograms and found that risk scores ran significantly higher for women later diagnosed with breast cancer, with some signals detectable up to six years in advance.
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Smart Ring Maker Oura Files for IPO Seeking Up to $2.2 Billion at a $15.6 Billion Valuation
Oura, the Finnish smart-ring maker, has set terms for a US IPO seeking up to $2.2 billion at a valuation as high as $15.6 billion, after reporting $1.21 billion in revenue for the nine months through June, up 74% from a year earlier.
