What You Should Know
The U.S. Food and Drug Administration (FDA) has cleared a new Apple Watch-based monitoring tool developed by Kneu Health for clinical tracking of Parkinson’s disease symptoms.Provides 24/7 continuous passive measurement of tremor alongside the platform's first-time capability to track dyskinesia—the involuntary movements often triggered as a side effect of long-term dopaminergic medications.Pairs continuous, passive smartwatch data with active, smartphone-based motor and
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Wearables in Healthcare| Medical Grade | News, Analysis, Insights - HIT Consultant
Ultrahuman Raises $70M to Build a Multimodal Human-Computer Interface for Health
What You Should Know
Bengaluru-based health intelligence company Ultrahuman announced a $70M financing round to evolve from a consumer wearable maker into an extensible human-computer interface (HCI) platform centered on the human body.The syndicate includes corporate heavyweights Qualcomm Ventures and Labcorp (via the Labcorp Venture Fund), alongside venture and growth investors Alpha Wave, Blume Ventures, Nexus Venture Partners, and Alteria Capital.Expands Pulsomics, an embedded opt-in
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BARDA Awards Flosonics Medical Up to $70M to Expand Wearable Ultrasound into Trauma Care
What You Should Know
Flosonics Medical secured a major development contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS).Awarded under BARDA’s Burn and Blast Medical Countermeasures program (Contract No. 75A50126C00006), the agreement includes initial funding of approximately $15 million, with a total potential value of up to ~$70
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Abbott Receives FDA Authorization for Libre Duo 10 Day, World’s First Dual Glucose-Ketone Sensing System
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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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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