FDA NewsPerspective

Personal ECG technology for Apple Watch cleared by FDA

AliveCor announced a personal ECG technology compatible with the Apple Watch has been cleared by the FDA.

The accessory (KardiaBand) allows Apple Watch users to get an ECG reading within 30 seconds using an integrated sensor to detect normal sinus heart rhythms and atrial fibrillation, according to a press release from the company.

According to the release, the technology is the first medical device accessory for the Apple Watch to receive FDA clearance.

"Today, ECGs are available only in offices and hospitals, using complex equipment, and usually only after a life-threatening event, for example a stroke,” Ronald P. Karlsberg, MD FACC, cardiologist and clinical professor of medicine at Cedars-Sinai Heart Institute and David Geffen School of Medicine at UCLA, said in the release. “With an ECG device on the wrist, AF can be detected wherever the patient is, 24 hours a day.”

According to Karlsberg, previous randomized trials have shown that first-generation ECG devices from AliveCor were superior to routine physician care.

AliveCor stated that it is simultaneously releasing SmartRhythm, a new feature within the Kardia app that uses artificial intelligence to evaluate the link between heart activity and physical activity.

When heart rate and activity are out of sync, the user is notified and encouraged to capture an ECG with KardiaBand or a portable ECG reader (KardiaMobile), according to the release.

"This is a paradigm shift for cardiac care as well as an important advance in health care," Karlsberg said in the release.

Disclosure: Karlsberg reports no relevant financial disclosures.

AliveCor announced a personal ECG technology compatible with the Apple Watch has been cleared by the FDA.

The accessory (KardiaBand) allows Apple Watch users to get an ECG reading within 30 seconds using an integrated sensor to detect normal sinus heart rhythms and atrial fibrillation, according to a press release from the company.

According to the release, the technology is the first medical device accessory for the Apple Watch to receive FDA clearance.

"Today, ECGs are available only in offices and hospitals, using complex equipment, and usually only after a life-threatening event, for example a stroke,” Ronald P. Karlsberg, MD FACC, cardiologist and clinical professor of medicine at Cedars-Sinai Heart Institute and David Geffen School of Medicine at UCLA, said in the release. “With an ECG device on the wrist, AF can be detected wherever the patient is, 24 hours a day.”

According to Karlsberg, previous randomized trials have shown that first-generation ECG devices from AliveCor were superior to routine physician care.

AliveCor stated that it is simultaneously releasing SmartRhythm, a new feature within the Kardia app that uses artificial intelligence to evaluate the link between heart activity and physical activity.

When heart rate and activity are out of sync, the user is notified and encouraged to capture an ECG with KardiaBand or a portable ECG reader (KardiaMobile), according to the release.

"This is a paradigm shift for cardiac care as well as an important advance in health care," Karlsberg said in the release.

Disclosure: Karlsberg reports no relevant financial disclosures.

    Perspective
    John P. Higgins

    John P. Higgins

    Arthur C. Clarke once remarked, “Any sufficiently advanced technology is indistinguishable from magic.” We may just have some new technology that fits this definition.

    Einthoven’s first ECG machine in 1901 weighed 600 lb — now, just 116 years later, we have a watch with a band that can take your ECG, and this weighs less than 1 lb. With the KardiaBand, the user, after placing their fingers on the device for 30 seconds, can get a real-time ECG tracing. The SmartRhythm algorithm can easily detect normal rhythm and senses when the heart rate and activity level of the user are not in sync, then will prompt the user to take an ECG strip. It can then accurately recognize an abnormal rhythm like AF. The KardiaBand is $199, and the app annual subscription is $99.

    This benefits our patients and us health care providers, as we will be able to better diagnose, manage and treat our patients with cardiac arrhythmias. This is nonintrusive and convenient, and studies have shown better rates of compliance than traditional Holter monitors. Instead of having the patient make an appointment or go to see their doctor for further testing, they can check right that instant, which is especially beneficial because some patients’ symptoms only rarely happen. Patients will learn more about their condition, get instant feedback and, thus, be better informed, and we the providers will have more objective information on them. And their ECG tracing can be texted or emailed to their provider, so if needed, they can get objective diagnosis and treatment in real time. With this information, we can better manage them and potentially reduce CV complications like MI and stroke. This is just the tip of the iceberg, as the iWatch is being tested now to diagnose hypertension, sleep apnea and diabetes. Stay tuned.

    We now have a watch that can monitor the electrical rhythms of our heart. I think Clarke would agree, that’s magic! 

    • John P. Higgins, MD, MPhil, MBA, FACC, FACP, FAHA
    • Professor of Medicine Sports Cardiologist The McGovern Medical School at UTHealth, Houston

    Disclosures: Higgins reports no relevant financial disclosures.

    Perspective

    "Technology is a useful servant but a dangerous master." – Christian Lous Lange

    The recent FDA approval of the AliveCor Apple Watch accessory KardiaBand highlights a next step toward expansion of the possibility of wearable medical device technology. Under ideal settings, patients may use this device to acquire single-lead ECG data via a wrist-worn device/Apple Watch accessory. This represents an incremental improvement to AliveCor's currently available device that works in conjunction with a smartphone app. The previous device, which was also FDA approved, requires patients to hold a credit card-sized device with two ECG leads while ECG data are acquired and transmitted to a device-connected smartphone or tablet. With the wrist-worn-enabled device, time to data acquisition can theoretically be at least minimally shortened. Additionally, the imminently available SmartRhythm algorithm can notify asymptomatic patients to initiate ECG data acquisition when discrepancies are detected between expected and measured heart rates. This has the potential to increase sensitivity in detecting arrhythmias.

    Much enthusiasm and press have justifiably accompanied the long-awaited FDA approval of the KardiaBand device. This newly available wearable device acquires patient-initiated, intermittently transmitted episodic ECG data streams that may inform heart rhythm-related clinical decision support. No doubt this technology has the potential to make or confirm cardiac rhythm diagnoses. Additionally, the possibility of this technology has investors, futurists, prognosticators, marketers and even some clinicians enthusiastic about its potential for improved diagnosis, patient engagement and, perhaps, even chronic disease management. However, these data still require human review and diagnosis verification before it can be considered safely actionable.

    Unfortunately, difficult to explain and arguably arcane concepts like artificial intelligence, deep neural networks and other charged descriptors of advanced data analytics have been invoked to conjure an overly grandiose vision for the use of wearable patient data of a new science of anticipatory medicine. Exuberant enthusiasm and industry and investor-driven optimism may overstate the potential value of KardiaBand and other developing medical technologies while also superseding the scientific method and undervaluing the investigation of novel technologies in less glamorous but real-world practical uses. As with most all patient data, clinical context and personalized interpretation inform clinicians of the value of any data. Real-world questions must be asked of these data, like: When much of clinical cardiology and medical care focuses on chronic disease management in patients with known diagnoses, how valuable is a patient-directed tool for arrhythmia diagnosis? How can millions of ECG data points most effectively be analyzed and displayed for clinical use? What is the cost of acquisition, analysis, storage and security of millions of ECG data streams? Who or what bodies will manage and pay for the stewardship and housing of these data? What are the unintended consequences and costs of the inevitable burden of incidental diagnoses detected in healthy populations?

    Technology and innovation in biological data acquisition are inevitable. As clinicians and consumers of limited and shared resources, prioritizing data streams and data types and maintaining disciplined approaches to the assessment of novel technologies may stem the tendencies of technologies and advancement to increase overall costs without providing meaningful clinical benefits. As physicians and scientists, we can partner with industry to ask relevant clinical questions that leverage innovative technologies to search for these answers. Consumer-directed wearable patient data has the potential to provide the answer — an abnormal heart rhythm, an out-of-range pulse rate or BP, unusual accelerometer data, etc — without an a priori clinically meaningful question. This possibility may inevitably create conflicts with the pursuit of virtuous science. 

    KardiaBand offers potentially enhanced access to more immediate ECG data for patients, clinicians and investigators. This enhanced access has the potential for novel opportunities to better understand human physiology. Increased accessibility to ECG data as a tool to better understand the human condition on an individual and population level may be the most meaningful application of the KardiaBand. The mobile and regular access to ECG data serially acquired over time in ambulatory patients with varying baseline physiologies and under differing states of health and stress may better inform normal and abnormal variability. This may provide new insights about various cardiac and even noncardiac disease states and treatments.

    • Ilan Kedan, MD, MPH
    • Cedars-Sinai Heart Institute

    Disclosures: Kedan reports no relevant financial disclosures.

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