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1.3.2 Clinical-Grade Wearables

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Medical-grade or clinical-grade wearables are those certified by the regulatory authorities like FDA for use by healthcare professionals. They can be used at home or in a clinic or hospital and expected to improve quality of life in chronic diseases and reduce the cost of long-term care.

With advances in technology, consumer wearables are slowly moving to the accuracy of medical-grade devices. A study by the Stanford University using the Apple watch with 4lac users showed that atrial fibrillation could be detected in accurately to a high degree. The users were alerted about the arrhythmia by the smart watch and resulted in half of them consulting a doctor [13]. But this study was not ideal as it was not controlled and subjects were not randomized [14]. Increasing number of high quality Medical-grade wearables are slowly turning the focus of smart wearables from fitness and activity trackers to clinical-grade devices which can be used by medical professionals [15]. The Apple Watch 4 has a medical-grade sensor approved by the FDA [16].

Current Health (Edinburgh, Scotland) has created a wireless AI device for monitoring patients in hospital and also at home. This device monitors patient’s vital parameters like pulse rate, respiratory rate, oxygen saturation, temperature, and patient mobility. It provides doctors with continuous data regarding health of their patient in real time. Current Health uses machine learning for analysis of this data and generates useful information and detect any significant changes [17]. An insertable cardiac monitor named Confirm Rx developed by Abbott healthcare can monitor ECG continuously for up to 2 years and can connect to a smartphone app (myMerlin) wirelessly through Bluetooth. It can also automatically send information to the doctor who can correlate symptoms with the heart rhythm [18]. Wrist-worn wearable devices as developed by researchers at the University of Michigan can also can detect circulating cancer cells in the blood, thereby revolutionizing cancer care [19].

A wearable cardiac defibrillator (WCD) is a portable device which is worn on the body and can deliver life saving shocks to terminate life-threatening ventricular arrhythmias. This can be used in lieu of an implantable cardioverter defibrillator (ICD) in patients who are not candidates for an ICD or early after a Myocardial infarction or are on the cardiac transplant list. In a study on uninsured patients with ischemic or nonischemic cardiomyopathy, WCD was shown to prevent unnecessary ICD implants in the subgroup of patients whose cardiac function subsequently improves following recovery thereby saving costs [20]. WCD can also be used in patients who are at high risk of ventricular arrhythmias and sudden cardiac death early after myocardial infarction. In a study of more than 8000 patients who had a WCD, 1.6% received shocks and 91% were revived from a cardiac arrhythmia. There was high rate of successful shock resulting in survival of 84%–95% of patients who received shocks [21]. WCD can also reduce the implantation rate of ICD in patients with heart failure who are diagnosed with cardiomyopathy, listed for transplant or on inotropic support. In a study on 89 patients with congestive heart failure with the above criteria, it was seen that 34% received an ICD, while 41.5% patients improved with a WCD who would have otherwise received an ICD [22].

Wearable waterproof sensors can also monitor the electrolytes in sweat and can analyze an athlete even underwater and monitor state of hydration and need for electrolytes. This can help enhance athletes performance [23]. Data from devices monitoring the mechanics of walking and the speed, symmetry of gait, and the length of stride can predict the development Alzheimer’s disease in patients. Patients can be monitored remotely by such mobile devices [24].

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