Updated FDA guidance on wellness software could let more AI-powered wearables skip formal medical device review, a shift welcomed by industry but criticized by safety advocates.
A new University of Chicago wearable cardiac patch uses on-device AI to detect dangerous heart arrhythmias with 99.6% accuracy, without needing a cloud connection.
Oura's new Ring 5 and Whoop's telehealth expansion both lean on AI to turn wearables into predictive health tools, even as the FDA and a proposed class-action lawsuit challenge the accuracy of their clinical-sounding claims.
A new Vyntra report estimates AI-driven scams caused $442 billion in global losses over the past year, with voice-cloning attacks on elderly victims emerging as one of the fastest-growing tactics.
OpenAI is targeting a second-half-2026 launch for its first hardware device, built with Jony Ive's design team around a screen-free, voice-driven interaction model rather than a traditional smartphone.
Generate Biomedicines and Zealand Pharma signed a deal worth up to $1.2 billion to design AI-generated multispecific protein therapeutics for obesity, marking Zealand's first move beyond peptide-based drugs.
UpDoc revealed that the FDA cleared its patient-facing LLM-based insulin management software back in December 2025, months before announcing it alongside pilot programs at Cleveland Clinic, Allegheny Health Network, and UCSF Health.
A new British Journal of Dermatology study of the SkinVision app found strong accuracy when clinicians captured images but a sharp drop-off when patients photographed their own skin, while a separate Dutch study of 2.2 million users found big jumps in both cancer detection and false-positive referrals.
The UK's MHRA unveiled a 2030 regulatory strategy built around AI and personalised medicine, promising faster trial reviews, a new AI and Digital Health centre, and closer alignment with the FDA on device recognition.
Google's new Health Guardian AI suite brings passive blood pressure and insulin resistance trend tracking to Fitbit Air, but the most useful features require a $9.99-a-month subscription, raising questions about equitable access to early health warnings.