Autonomic-vascular dysregulation in CKD-associated hypertension: a narrative review with evidence hierarchy
DeviceTalks Minnesota 2026 show preview: Speakers, exhibitors and more
It’s almost time for our May 4 DeviceTalks Minnesota show at the University of Minnesota’s McNamara Alumni Center in Minneapolis. We’ve got a great lineup of keynotes — Abbott’s Lisa Earnhardt, Solventum’s Heather Knight, Mike Blue at HistoSonics and Medical 21’s Manny Villafaña — plus more interviews and panels of experts from medical device OEMs…
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Baxter discloses executive pay under new CEO and golden parachute for the last CEO
Baxter International disclosed how much it paid its new CEO last year in a recent filing with the U.S. Securities and Exchange Commission. The medical device manufacturer also disclosed pay packages for other current and former executives — including a severance payment for its former CEO — and reported higher pay for its median employee. Baxter’s…
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Benefit of the N-of-1 Approach Versus Aggregate Analysis in Tracking Individual Trajectories During Pregnancy: Comparison of Longitudinal Wearable Observational Studies
Background: Personal digital health technologies (DHTs) enable real-time monitoring of physiological metrics and behavioral data, including heart rate variability (HRV), supporting analysis of pregnancy-related conditions and personalized care throughout the perinatal period. While recent studies demonstrate the utility of personal DHTs in tracking pregnancy-related symptoms, they often rely on aggregate statistical methods that overlook individual variability. Objective: This study aims to compare aggregate and individual-level analyses of DHT data for pregnancy-related conditions, using the comprehensive BUMP (Better Understanding the Metamorphosis of Pregnancy) dataset to highlight the importance of individual variability and data heterogeneity. Methods: We analyzed wearable and self-reported data from 256 participants enrolled in the BUMP study (January 2021 to May 2022), including HRV, sleep, and fatigue measured via Oura Rings and smartphone surveys. Individual-level (N-of-1) trajectories were evaluated and compared with aggregate results to uncover personal and collective trends. A statistical method was developed to assess the influence of adverse events and severe symptoms, while case studies explored confounding and modifying factors underlying heterogeneity. Comprehensive statistical analysis included the coefficient of determination, Kolmogorov-Smirnov tests, likelihood ratio tests, and Welch tests, with interindividual variability flagged based on high-variability thresholds. Results: Substantial interindividual variability was observed across all features. Only 4.76% (12/256) of participants exhibited an HRV inflection at the aggregate week-33 inflection point, with a coefficient of variation of 14.24%. The median value of the gestational week in individual fatigue troughs was 23 (IQR 8; range 8-38) weeks, differing from aggregate estimates. Distributional comparisons showed no statistically significant differences in individual-level model fit (²) by pregnancy complications or age ( values ranging from .06 to .99 across all model fit comparisons). Case studies further highlighted both intraindividual and interindividual differences, emphasizing the importance of considering external factors, such as adverse events and severe symptoms. Conclusions: Our findings show that aggregate wearable data often fail to generalize across populations, oversimplifying pregnancy-related physiological and subjective changes. This simplification can obscure individual trajectories, leading to generalized insights that may not reflect many pregnant women’s experiences. Our results highlight the impact of heterogeneity on pregnancy outcomes, emphasizing the need to move beyond one-size-fits-all models and leverage DHT for personalized care.
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Why Microbot Medical developed a fully disposable surgical robot
Microbot Medical is creating a “whole new category in robotics” with its fully disposable Liberty endovascular navigation surgical robot, co-founder and CEO Harel Gadot says. The medical device developer designed Liberty as a single-use system to overcome adoption barriers in robot-assisted surgery. The main barrier in endovascular surgical robotics is extended setup time, Gadot said, followed…
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Digital Phenotyping via Passive Network Traffic Monitoring: Prospective Observational Study in University Students
Background: Digital behaviors such as sleep, social interactions, and productivity reflect how individuals structure their daily lives. Among university students, online activity patterns mirror academic schedules, social rhythms, and lifestyle habits, with disruptions linked to sleep, stress, and well-being. Existing approaches—including wearables, apps, and surveys—depend on self-report or active participation, limiting long-term adherence. Passive sensing of network traffic offers a scalable alternative for the unobtrusive capture of smartphone usage patterns that preserves privacy. Objective: This study evaluated the degree to which encrypted smartphone network traffic, collected via a standard virtual private network (VPN), can capture patterns of digital behavior. We assessed feasibility (sustained data capture) and acceptability (usability, burden, and privacy perceptions) and examined how traffic-derived features reveal aspects of digital behavior—including timing, intensity, and regularity—relevant to health and daily functioning. Methods: We conducted a 2-week prospective observational study at New York University. Participants installed the WireGuard VPN client on personal smartphones, enabling passive capture of encrypted network traffic. Feasibility was assessed using a mixed methods approach combining quantitative measures of user retention and data coverage with qualitative analysis of semistructured exit interviews. Acceptability was evaluated using the System Usability Scale, NASA Task Load Index, and qualitative interview analysis. Exploratory analyses visualized traffic-derived features in relation to digital activity patterns. Results: Thirty-eight students consented, of whom 29 (76.3%) contributed valid network traffic data and formed the analytic cohort. Within this cohort, 93% of participants (27/29; Wilson 95% CI 78%‐98%) contributed at least 5 days of monitoring, corresponding to 71% retention relative to all consented participants (27/38; Wilson 95% CI 55%‐83%). The mean data coverage within the analytic cohort (n=24) was 74.1% (SD 19.3%; median 77.1%, IQR 63.6%-90.0%; bootstrap 95% CI 66.3%‐81.4%). These participants contributed an average of 311.6 (∼13 d, SD 3.5) hours of monitored traffic, ranging from 121 to 496 hours. Acceptability outcomes were evaluated among participants completing the exit survey and interview. Usability ratings were high (System Usability Scale score: mean 78, SD 14.96), and perceived workload was low (NASA Task Load Index scores were minimal). Participants described the system as easy to install, unobtrusive, and generally trustworthy, although some reported temporarily disabling the VPN during activities they considered private. No inferential statistical tests were conducted; analyses were descriptive. Exploratory analyses indicated that traffic-derived features reflected daily digital activity rhythms and revealed distinctive lifestyle patterns, including gaming and irregular late-night food delivery use. Conclusions: VPN-based monitoring of encrypted smartphone traffic was feasible and acceptable, enabling sustained passive data collection with minimal burden. This approach shows promise as a scalable, device-agnostic method for digital phenotyping that captures fine-grained behavioral rhythms while preserving privacy. With broader validation, this technique could expand the toolkit for studying health and well-being in everyday life.
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STAT+: Zap in a cap: How one neurotech startup is using a hat to treat depression
Wake up. Brush your teeth. Wash your face.
And put on your lifesaving baseball hat.
That’s right. If you have treatment-resistant depression, this could be the regular morning routine in your future. The hat would activate a blueberry-sized device implanted in your skull that sends a pulse of electricity into your brain.
This is Jacob Robinson’s vision — and it got closer to reality on Friday after the Food and Drug Administration approved a request from Robinson’s startup, Motif Neurotech, to start an initial feasibility trial to test the efficacy of their device in treating depression that hasn’t responded to other treatments. Scientists have been zapping brains to alleviate depression for decades through a method called transcranial magnetic stimulation, or TMS. Motif wants to do the same thing, but with a twist.
A Random Controlled Trial of Home-based Digital Therapy for Treating ADHD in Children
Interventions: Device: Home-based digital therapy with brain-controlled games
Sponsors: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Recruiting
FDA warns device manufacturers of nitrosamine impurities that could cause cancer
The FDA Center for Devices and Radiological Health (CDRH) is warning manufacturers of drug-device combination products of the potential for nitrosamine impurities, which are classified as probable carcinogens associated with forms of cancer. The FDA did not name specific devices or kinds of devices that could be at risk in the letter it sent to…
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