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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Publication date: Available online 8 November 2018Source: The Lancet NeurologyAuthor(s): David J Seiffge, David J Werring, Maurizio Paciaroni, Jesse Dawson, Steven Warach, Truman J Milling, Stefan T Engelter, Urs Fischer, Bo NorrvingSummaryBackgroundAbout 13–26% of all acute ischaemic strokes are related to non-valvular atrial fibrillation, the most common cardiac arrhythmia globally. Deciding when to initiate oral anticoagulation in patients with non-valvular atrial fibrillation is a longstanding, common, and unresolved clinical challenge. Although the risk of early recurrent ischaemic stroke is high in this populat...
Source: The Lancet Neurology - Category: Neurology Source Type: research
This article provides general principles for appropriate risk stratification and selection of anticoagulation therapy in Korean patients with AF. This guideline deals with optimal stroke prevention, screening, rate and rhythm control, risk factor management, and integrated management of AF. PMID: 30403013 [PubMed]
Source: Korean Circulation Journal - Category: Cardiology Tags: Korean Circ J Source Type: research
CONCLUSIONS: The knowledge of arrhythmia and anticoagulation is better regarding the safety issues among subjects on NOACs compared with those on VKAs. Irrespective of the type of oral anticoagulation therapy, education of AF patients should be improved. PMID: 29528483 [PubMed - indexed for MEDLINE]
Source: Kardiologia Polska - Category: Cardiology Authors: Tags: Kardiol Pol Source Type: research
CONCLUSIONS: The limited available evidence for HRU burden among patients receiving oral anticoagulation for NVAF suggests that DOACs (particularly apixaban and dabigatran) offer some degree of benefit in terms of HRU outcomes, compared with warfarin. Further work is required to understand HRU outcomes in patients receiving DOACs. PMID: 30380959 [PubMed - as supplied by publisher]
Source: Current Medical Research and Opinion - Category: Research Tags: Curr Med Res Opin Source Type: research
Atrial fibrillation (AF) is the most common arrhythmia seen in clinical practice, and has a major impact on morbidity and mortality; linked to one in 12 deaths in Australia [2]. Though appropriate rhythm management and stroke prevention are essential, arguably, prevention is likely to achieve the greatest impact on these outcomes. These Australian-first guidelines [1], developed by the Heart Foundation and the Cardiac Society of Australia and New Zealand, incorporate the latest contemporary evidence in AF prevention by recommending a holistic approach.
Source: Heart, Lung and Circulation - Category: Cardiology Authors: Tags: Editorial Source Type: research
Abstract Understanding the anatomy, physiology, and arrhythmogenic and thrombogenic roles of the left atrial appendage (LAA) has become very important. The potential deleterious effects of this chamber in patients with atrial fibrillation have led to the development of specific treatments for this structure. It has been established that the LAA is the area where the vast majority of thrombi in nonvalvular atrial fibrillation are formed and that some LAA morphologies may actually facilitate thrombi formation and risk stratification for thromboembolic events in patients with low CHA2DS2-VASc scores. Likewise, clinic...
Source: Circulation - Category: Cardiology Authors: Tags: Circulation Source Type: research
Authors: Székely O, Miyazawa K, Lip GYH Abstract INTRODUCTION: Atrial fibrillation (AF) is associated with high morbidity and mortality rates due to thromboembolic complications, and anticoagulation is central to the management of this common arrhythmia to prevent acute thromboembolic events. The traditional anticoagulants: heparin, fondaparinux, and vitamin K antagonists (VKA, e.g. warfarin, acenocoumarol or phenprocoumin) have long served as pharmacotherapy for ischemic stroke prophylaxis. Areas covered: In this review article, the authors provide an overview on current and emerging pharmacotherapy for isc...
Source: Expert Opinion on Pharmacotherapy - Category: Drugs & Pharmacology Tags: Expert Opin Pharmacother Source Type: research
Authors: Trailokya A, Hiremath JS Abstract Atrial fibrillation (AF) is commonly occurring arrhythmia in clinical practice. AF is easy to recognize but difficult to treat. Stroke is the most devastating complication of AF and is associated with a huge disease burden on the society. Effective stroke prevention is a priority for patients with AF. Two-thirds of strokes due to AF are preventable with suitable anticoagulant therapy. VKA like warfarin, acenocoumarol remains the gold standard for stroke prevention in AF (SPAF). However, it is associated with numerous limitations such as a high risk of drug-drug, drug-food ...
Source: Journal of the Association of Physicians of India - Category: General Medicine Tags: J Assoc Physicians India Source Type: research
Abstract Atrial fibrillation (AF) is an age-related arrhythmia, particularly affecting elderly patients. The ultimate goals in the treatment of AF are to improve prognosis and quality of life. Anticoagulants are effective for stroke prevention in AF patients, however, managing anticoagulation in elderly patients is especially challenging; requiring a comprehensive assessment of the patient and deep understanding of available therapies and doses to maximize the net benefit. This review summarizes available evidence on the efficacy and safety of anticoagulation therapy, and provides contemporary updates on the manag...
Source: Ageing Research Reviews - Category: Genetics & Stem Cells Authors: Tags: Ageing Res Rev Source Type: research
Conclusions: Compared with norepinephrine, vasopressin could not improve the postoperative outcomes in patients with pLVD after cardiac surgery. Vasopressin should be cautious to be used as a first-line vasopressor agent in postcardiac vasoplegic shock.
Source: Shock - Category: Emergency Medicine Tags: Clinical Science Aspects Source Type: research
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