What You Should Know
The U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization to Abbott for its Libre Duo 10 Day system, establishing the new integrated continuous glucose and ketone monitoring (iCGK) regulatory benchmark alongside standard iCGM status.Libre Duo monitors glucose and continuously tracks rising ketones in the background to prevent diabetic ketoacidosis (DKA), a critical emergency for which U.S. hospital admissions have increased by 55% over the
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Wearables in Healthcare| Medical Grade | News, Analysis, Insights - HIT Consultant
Fitbit Founders Unveil Luffu Link, Wearable for Family Health, Safety and Connection
What You Should Know
Fitbit co-founders James Park and Eric Friedman have officially unveiled Luffu Link, a screenless, jewelry-inspired LTE health and safety wearable designed specifically for family caregiving and aging in place.Luffu Link marks the first hardware device in a broader ecosystem spanning the Luffu smartphone app (introduced in February 2026 and currently in public beta), the wristband, and an upcoming dedicated in-home display device slated for later this year.Addresses the
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FDA Grants De Novo Authorization to Avulux, Establishing First Device Classification for Migraine Light Sensitivity
What You Should Know
The U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization to Avulux, establishing a first-of-its-kind, FDA-recognized medical device classification for precision optical filters designed to manage migraine-associated light sensitivity.Decreases the impact of light sensitivity in patients diagnosed with episodic migraine aged 12 years and older, serving as an over-the-counter, non-invasive complement to usual care and pharmacological
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Wellness Project Launches Verified Google Health Integration Ahead of Fitbit API Sunset
What You Should Know
Wellness Project launched a direct, verified integration with the new Google Health API, providing Fitbit and Pixel Watch users with an open pathway to sync wearable metrics into a unified, AI-ready longitudinal health record.The integration comes ahead of Google’s planned September 2026 retirement of the legacy Fitbit Web API, which requires developers to migrate to Google Health, adopt new OAuth infrastructure, and pass restricted-scope verification.In addition to
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SoundHealth Raises $12.25M to Expand Non-Invasive Medical Wearables
What You Should Know
Medical technology firm SoundHealth has closed an oversubscribed Series A round led by Shangbay Capital, bringing its total venture funding to $12.25M.Flagship FDA-cleared wearable device, Sonu, has delivered over 500,000 acoustic resonance treatment sessions for patients ages 12+, becoming a leading non-drug alternative to corticosteroid nasal sprays for allergic and non-allergic rhinitis.Leverages smartphone facial scanning algorithms to construct custom digital sinus
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UC San Diego Engineers Develop Battery-Free Wearable Patch for Real-Time Parkinson’s Dosing
What You Should Know
Engineers and neuroscientists at UC San Diego have developed a soft, sweat-powered fingertip patch that continuously monitors levodopa levels in patients with Parkinson’s disease without requiring external batteries or blood draws.Features a specially engineered absorbent gel packed with salts and benign solvents that passively draws sweat from the fingertip's dense network of sweat glands via osmosis.Embedded enzymes react with levodopa in sweat to generate both the
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Withings Medical Launches AI-Backed Clinical Service for Continuous Chronic Disease Management
What You Should Know
Connected health pioneer Withings has announced the launch of Withings Medical, a new clinical care delivery branch marking the company's evolution from passive biometric tracking to direct care provision.The service launches first for the U.S. Medicare-eligible population as a participant in CMS’s new ACCESS Model (Advancing Chronic Care with Effective, Scalable Solutions), an outcomes-aligned chronic care initiative launched nationally on July 5, 2026.Operating through
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Wearable Tech Startup The90 Launches $299 UV-Tracking Smart Jewelry
What You Should Know
Preventative skin health wearable pioneer The90 has formally launched out of stealth with The90™ Gem, a high-end smart jewelry pendant and companion app designed to track personal UV exposure.The device targets a massive market gap in healthy skin aging: up to 90% of visible skin damage, wrinkles, and fine lines are caused by cumulative, everyday ultraviolet light exposure rather than chronological aging.Unlike generic, location-based smartphone weather apps, the wearable
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Dr. Eric Rosenberg Completes First Cataract Surgery Using Apple Vision Pro and ScopeXR
What You Should Know
Dr. Eric Rosenberg of SightMD became the first surgeon to perform a cataract surgery using the Apple Vision Pro in October 2025.The procedure utilized ScopeXR, a custom-built mixed reality surgical platform that streams live feeds from 3D digital microscopes directly into the headset.Dr. Rosenberg has since used the device to assist in hundreds of additional cases, demonstrating the hardware's viability for routine surgical use.The system enables real-time remote
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ŌURA Acquires Galen AI to Pioneer Unified Health Companion, Merging Clinical Records with Continuous Biometrics
What You Should Know
ŌURA has officially acquired Galen AI, a startup founded by Stanford graduates that specializes in unifying fragmented health data from over ten thousand healthcare systems. Financial details of the acquisition were not disclosed. The acquisition allows Oura to integrate medical records, lab results, and medications directly with the continuous biometric data captured by the Oura Ring.Galen AI’s founders and their specialized AI infrastructure will join the Oura team
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