What You Should Know
Connected health hardware pioneer Withings and comprehensive diagnostic platform Function announced an enterprise integration, creating a bi-directional data bridge connecting continuous daily physiological telemetry with longitudinal clinical lab testing.The technical bridge allows Withings daily metrics—spanning body composition, segmental muscle mass, visceral fat, blood pressure, and sleep staging—to sync automatically into the Function app. In turn, Function’s
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Wearables in Healthcare| Medical Grade | News, Analysis, Insights - HIT Consultant
Theranica’s 53,000-Patient Study Proves 30-Day Longitudinal Patterns Predict Migraines with 91% Precision
What You Should Know
Neuromodulation digital therapeutics pioneer Theranica announced the publication of a landmark, peer-reviewed clinical validation study in Neurology® Open Access evaluating Your Day Ahead, an integrated machine learning (ML) feature inside the Nerivio® mobile app.The investigation, titled “Machine Learning Assessment of Next-Day Migraine Likelihood Using Data From 53,000 App Users Living With Migraine,” analyzed 770,473 daily diary reports from 53,065 real-world users of
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Ultrahuman Partners with HealthEx to Integrate Clinical Health Records into Smart Ring Biometric Timeline
What You Should Know
Smart ring and wearable health technology company Ultrahuman announced the rollout of the HealthEx PowerPlug, integrating personal electronic medical records with continuous biometric streams from the Ultrahuman Ring.The feature is powered by HealthEx, a consumer-directed health data platform that leverages the federally backed Trusted Exchange Framework and Common Agreement (TEFCA) to discover and retrieve longitudinal patient health records across nationwide health
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Flow Neuroscience Launches FDA-Approved At-Home tDCS Treatment for Major Depressive Disorder
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Swedish neurotechnology company Flow Neuroscience officially launched FL-100 across the United States, introducing the first FDA-approved at-home transcranial direct current stimulation (tDCS) treatment for depression to the American market.Backed by formal premarket approval (FDA PMA P230024), the prescription-only medical device is indicated for adults (18+) with moderate to severe major depressive disorder (MDD) in the current episode who are not treatment-refractory,
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FDA Clears Kneu Health Apple Watch Tool for 24/7 Parkinson’s Tremor and Dyskinesia Monitoring
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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Ultrahuman Raises $70M to Build a Multimodal Human-Computer Interface for Health
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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
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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
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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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