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FDA’s AI-Enabled Medical Device List Tops 1,600, With Clearances on Pace to Set a New Record
The FDA's list of authorized AI-enabled medical devices passed 1,600 in September, with 2026 clearances on pace to set a new annual record, even as the agency says its own list likely undercounts the true total.
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Insilico Dosed the First Patient in a Trial for a Fully AI-Discovered Drug
Insilico Medicine dosed the first patient in a trial for a candidate it says was discovered and designed using AI, a milestone in the race to prove computational drug discovery can produce viable therapeutics.
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Mayo Clinic Let Its Nurses Pitch AI Agents — More Than 450 Entries Later, Microsoft Is Helping Build the Finalists
Mayo Clinic challenged its own nurses to pitch autonomous AI agent ideas, drawing more than 450 entries and 33 finalists now building prototypes with Microsoft, with the full nursing department set to vote on which ones move forward.
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St. Luke’s Health System Taps hellocare.ai to Put AI-Assisted Virtual Nursing in Every Idaho Hospital Room
St. Luke's Health System has selected hellocare.ai to deploy AI-assisted virtual nursing, virtual sitting and connected-room technology across its southern Idaho hospitals, part of a fast-growing national push into enterprise virtual care.
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Character.AI and Google Settle Five Lawsuits Over Chatbots and Teen Mental Health Harm
Character.AI and Google settled five lawsuits alleging the company's chatbot companions contributed to teen suicides and severe mental health harm, even as a broader wave of similar litigation against AI chatbot makers continues to grow.
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Nanowear’s Wrist Patch Wins FDA Breakthrough Status for Non-Invasive Vascular Monitoring
Nanowear's SimpleSense-Wrist patch won FDA Breakthrough Device Designation for non-invasive vascular monitoring, extending the company's fabric-sensor wearable platform into a technically challenging new cardiovascular category.
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Abbott Wins FDA Clearance for First Wearable to Track Glucose and Ketones Together
Abbott won FDA clearance for the first wearable that continuously tracks both glucose and ketones, a combination clinicians say could help catch dangerous ketoacidosis earlier in diabetes patients taking SGLT2 inhibitor medications.
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HIMSS Brings Hospital Executives to San Diego for a Three-Day AI Reckoning
HIMSS's AI Executive Leadership Summit and AI in Healthcare Forum brought hospital leaders to San Diego to confront a widening gap between fast-moving AI adoption and the governance infrastructure needed to deploy it safely.
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Hospitals Push Back as Insurers Accuse Them of Using AI to Inflate Medical Billing Codes
The American Hospital Association pushed back on insurer accusations that hospitals use AI to inflate billing codes, framing the dispute as part of a broader arms race in which both payers and providers deploy AI in claims processing.
