NYT Report: Apple Watch ‘ should not be considered a medical device ’

The new electrocardiogram-equipped Apple (NSDQ:AAPL) Watch should not be considered a medical device, according to a new report from the New York Times. The article, written by Indiana University School of Medicine pediatrics professor Aaron Carroll, calls into question the downsides of the newly released device and the potential for both false positives and false negatives. Carroll acknowledged the possible positives of the device, including the ability for physicians to monitor patients from a distance and diagnosing heart problems in individuals that would possibly go undetected, but said that “just because something seems like a good idea doesn’t mean it is.” “No screening test is perfect,” Carroll wrote in the Times article. “In general, we would like people who are sick to have a positive screening result, and people who are well to have a negative result. Unfortunately, people who are sick sometimes have a negative result. Those are false negatives. People who are well sometimes have a positive result. Those are false positives.” Both outcomes are worrisome, Carroll suggested in the report. He added the false negatives may cause someone who needs medical help to not seek it, but said that because “relatively few people have serious, undiagnosed arrhythmias with no symptoms” that it wasn’t a major concern. False positives, however, end up costing time time, money and emotional distress, according to the Ti...
Source: Mass Device - Category: Medical Devices Authors: Tags: Business/Financial News Diagnostics mHealth (Mobile Health) Apple Source Type: news

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Conclusions: Embolism associated with asymptomatic carotid stenosis shows circadian variation with highest rates 4–6 h before midday. This corresponds with peak circadian incidence of stroke and other vascular complications. These and ASED Study results show that monitoring frequency, duration, and time of day are important in ES detection. Introduction Transcranial Doppler (TCD) detected microembolism in the ipsilateral middle cerebral artery (MCA) may help stratify the risk of stroke and other arterial disease complications in persons with advanced (≥60%) asymptomatic carotid stenosis. If so, this techniqu...
Source: Frontiers in Neurology - Category: Neurology Source Type: research
Authors: Li X, Sun Z, Du X, Liu H, Hu G, Xie G Abstract Atrial fibrillation (AF) is a common cardiac arrhythmias, which increases the risk and severity of ischemic stroke. For predicting ischemic stroke in AF patients, a risk prediction model that can achieve both good model discrimination (e.g., A UC) and statistical significance ofpredictors is required in real clinical practices. In this paper, we propose a new bootstrap-based wrapper (Boots-wrapper) method of feature selection, and apply this method on Chinese Atrial Fibrillation Registry data to develop 1-year stroke prediction models in AF. The proposed metho...
Source: AMIA Annual Symposium Proceedings - Category: Bioinformatics Tags: AMIA Annu Symp Proc Source Type: research
Conclusion An occult preexisting atrial fibrillation may lead to unnecessary percutaneous foramen ovale closure in a significant proportion of patients. A 6-month loop-recorder monitoring may improve the patient oriented decision-making.
Source: Journal of Cardiovascular Medicine - Category: Cardiology Tags: Research articles: Arrhythmias Source Type: research
Abstract: Atrial fibrillation is the most common arrhythmia in clinical practice, and age is one of the strongest predictors/risk factors for ischemic stroke in patients with atrial fibrillation. Elderly patients, in particular patients aged 80 years and older, are at higher risk of both ischemic and bleeding events compared with younger patients. Vitamin K antagonists (VKAs) reduce the risk of ischemic stroke, especially in the elderly, but increase the bleeding risk. In addition, frequent international normalized ratio monitoring is needed to ensure the optimal level of anticoagulation. Furthermore, VKAs have multiple ...
Source: Journal of Cardiovascular Pharmacology - Category: Cardiology Tags: Review Article Source Type: research
Atrial fibrillation (AF) is the most common arrhythmia worldwide associated with significant morbidity and mortality and represents a significant health care burden. Goals of AF treatment include prevention of cardioembolic stroke using anticoagulation and device therapy and restoration of sinus rhythm using antiarrhythmic drugs or catheter ablation techniques. A comprehensive assessment of cardiac chamber size and function is often started with echocardiography as a first line diagnostic imaging strategy.
Source: Journal of Cardiovascular Computed Tomography - Category: Radiology Authors: Source Type: research
ConclusionImproved monitoring systems make them indispensable tools for detecting emboligenic arrhythmias in the aftermath of cryptogenic stroke. Other studies of greater powers are needed to make a finer selection of patients to benefit.
Source: Archives of Cardiovascular Diseases Supplements - Category: Cardiology Source Type: research
Abstract Stroke is a devastating complication of atrial fibrillation (AF) the odds of which can be reduced by use of oral anticoagulation based on the stroke risk score.1,2 Patients with asymptomatic clinical AF have a similar stroke risk as patients with symptomatic clinical AF.3 Thus far, electrocardiographic- (ECG) or Holter monitor-detected AF is a prerequisite before use of oral anticoagulation,1,2 because the guideline recommendations are based on studies that included only ECG- or Holter-detected AF ('clinical' AF).1,2 In the past decades increasing number of cardiac implantable electronic devices (CIED) ha...
Source: Circulation - Category: Cardiology Authors: Tags: Circulation Source Type: research
ROCHESTER, Minn. -- Atrial fibrillation is a common arrhythmia that affects an estimated 30 million people worldwide. New research shows that catheter ablation, a common cardiovascular procedure, appears no more effective than drug therapy to prevent strokes, deaths and other complications in patients with atrial fibrillation. But patients who receive catheter ablation experience much greater [...]
Source: Mayo Clinic Research News - Category: Research Source Type: news
Sound, rhythm, rate, structure, function – countless features of the heart are measured to keep it healthy for as long as possible. Recently, an army of digital health technologies joined the forces of traditional preventive tools in cardiology to counter stroke, heart attack, heart failure or any other cardiovascular risks. In the future, minuscule sensors, digital twins, and artificial intelligence could strengthen their ranks. Let’s see what the future of cardiology might look like! Fitness trackers, chatbots and A.I. against heart disease Let’s say 36-year-old Maria living in Sao Paulo in 2033 d...
Source: The Medical Futurist - Category: Information Technology Authors: Tags: Artificial Intelligence in Medicine Future of Medicine Health Sensors & Trackers Portable Diagnostics cardiology cardiovascular cardiovascular diseases digital digital twin health trackers heart heart health heart rate heart soun Source Type: blogs
Aims Atrial fibrillation incidence is increasing due to ageing population and electrical cardioversion (ECV) is overused because of atrial fibrillation recurrences. Study's aim was to evaluate value of novel three-dimensional echocardiographic-derived left atrial conduit (LAC) function quantification in predicting early atrial fibrillation recurrence after ECV. Methods We included 106 patients [74 (64–78) years] who underwent ECV for persistent nonvalvular atrial fibrillation. For all clinical data and simultaneous left atrial and left ventricular (LV) three-dimensional full-volume data sets were available befor...
Source: Journal of Cardiovascular Medicine - Category: Cardiology Tags: Research articles: Arrhythmias Source Type: research
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