Groundbreaking AI Technology Receives FDA Approval
RapidAI has achieved a significant milestone with FDA 510(k) clearance for their revolutionary Lumina 3D system. This automated 3D imaging reconstruction solution leverages cutting-edge AI technology to replace traditional…
Welcome to the January edition of Digital Health Digest, your trusted source for the latest in digital health and healthcare technology!In this episode, we cover major updates transforming the digital health landscape—from Bicycle Health…
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Body composition prediction from 3D optical imagery has previously been studied with linear algorithms. In this study, we present a novel application of deep 3D convolutional graph networks and nonlinear Gaussian process regression for…
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Real-time monitoring of hydration biomarkers in tandem with biophysical markers can offer valuable physiological insights about heat stress and related thermoregulatory response. These metrics have been challenging to achieve with wearable sensors. Here we…
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AI Optics, an AI-enabled medical device company, has received FDA 510(k) clearance for its Sentinel Camera.The handheld retinal imaging system captures high-quality images of the human eye, helping to address gaps in retinal disease…
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What You Should Know:
– GE HealthCare has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its updated portfolio of Voluson™ Expert Series ultrasound systems.
– The Voluson Expert 22, 20,…
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Hong Kong-based startup PanopticAI has obtained regulatory approval in the United States for its contactless pulse rate measuring application. It received the US Food and Drug Administration’s 510(k) clearance for the PanopticAI Vital Signs app…
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Early screening and evaluation of infant motor development are crucial for detecting motor deficits and enabling timely interventions. Traditional clinical assessments are often subjective, without fully capturing infants’ “real-world” behavior. This has sparked interest…
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Exercise and mindfulness-based interventions have growing evidence for managing fatigue and comorbid symptoms; however, packaging them in a cohesive digital way for patients undergoing cancer treatment has not been evaluated. We conducted a randomized…
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Cardiac wall motion abnormalities (WMA) are strong predictors of mortality, but current screening methods using Q waves from electrocardiograms (ECGs) have limited accuracy and vary across racial and ethnic groups. This study aimed to…
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