Smart devices designed with health in mind
MDlinx Dec 06, 2023
Each year, companies like Fitbit, Garmin, and Apple introduce more advanced smart devices and wellness apps designed to compete in the ever-growing health and wellness industry. Typically released as wearables, these techy devices track the user's every move, recording and analyzing their daily steps, sleep, and more, with the purported aim to improve overall wellness.
As the competition for smarter wearables continues to heat up, brands have further medicalized their offerings, and each brand now has multiple options and versions with unique features and price points.
Popular wellness apps and wearables
Fitbit produces one of the most popular examples. Fitbit Premium members can track their heart rate, breathing rate, skin temperature, and oxygen saturation via wristwatch.
Howely EK. Fitbit Watch vs. Apple Watch: Which Is Better? US News & World Report. June 21, 2023.
In the higher end versions of the Fitbit and Apple Watch, users are notified of an abnormal or irregular heart rate, and an ECG app provides electrocardiogram data with no additional sensors required.
Some models can even detect falls and notify emergency services when the user needs help, and can share where the fallen user is located in real time.
FDA-approved for heart health
The above smartwatches can provide motivation and accountability for a healthier lifestyle. In addition, certain heart-monitoring features are getting approved by the FDA to help flag (but not diagnose) potential concerns. Searching the FDA’s online database is the easiest and most accurate way to see which capabilities have received the FDA’s stamp of approval.
Devices@FDA. US Food & Drug Administration. October 9, 2023.
According to the FDA database, current approvals include:
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Fitbit ECG App: September 11, 2020
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Apple ECG App: October 8, 2020
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Fitbit Irregular Rhythm Notifications: April 8, 2022
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Apple Atrial Fibrillation History Feature: June 3, 2022
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Apple Irregular Rhythm Notification Feature (IRNF): July 21, 2023
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Garmin ECG App: January 12, 2023
Beware of misleading claims
The FDA encourages consumers to verify health-related claims on all smart devices. Several misleading logos, including FDA Registered, FDA Certified, and FDA Registration Certificate, are used to imply an endorsement by regulators that simply isn’t there.
The FDA explains, “Owners or operators of places of business that are involved in the production and distribution of medical devices intended for use in the United States are generally required to register annually with the FDA.”
However, “When a facility registers its establishment and lists its devices, the resulting entry in the FDA's registration and listing database does not denote approval, clearance, or authorization of that facility or its medical devices.”
Are There "FDA Registered" or "FDA Certified" Medical Devices? How Do I Know What Is FDA Approved? US Food & Drug Administration. March 3, 2021.
Smart devices effectiveness
Aside from specific FDA-approved functions, evaluating the accuracy of wearables isn’t always straightforward. The expensive marketing behind these products can make it difficult to trust seemingly unbiased online reviews.
A systematic review published in the Journal of Medical Internet Research assessed the “accuracy and acceptability” of several wearable health trackers.
Germini F, Noronha N, Borg Debono V, et al. Accuracy and acceptability of wrist-wearable activity-tracking devices: systematic review of the literature. J Med Internet Res. 2022;24(1):e30791.
Investigators observed that step counts, heart rate, and energy expenditure were the most commonly measured outcomes.
For step counts, the Fitbit Charge was deemed fairly accurate compared with other products, with a mean absolute percentage error under 25%. To measure heart rate, the Apple Watch was even more precise, with a lower than 10% error rate.
Unfortunately, none of the brands accurately measured energy expenditure, suggesting potential problems for users relying on the data to lose or gain weight.
New devices on the horizon
More advanced, upcoming devices go beyond the fitness realm, aiming to bring medical testing and care closer to home. One example is AnemoCheck, created by Sanguina.
AnemoCheck is an app that estimates hemoglobin levels based on a picture taken by a smartphone of the user's fingernails. This FDA-approved program intends to help people with blood disorders—including sickle cell and thalassemia—monitor hemoglobin levels at home.
In addition, AmenoCheck Home was approved in 2023 as a home hemoglobin test kit. With a prescription, patients can take a fingerstick blood sample, test it at home, and get results within 2 minutes.
Nikolic J. AnemoCheck Home Cleared by FDA for Patients With SCD. RareDiseaseAdvisor. October 6, 2023.
AnemoCheck is just one product in a rapidly expanding world of smart devices. Clinicians must stay curious and informed as patients continue to seek high-tech healthcare solutions.
What this means for you
Wearable fitness trackers have been on the market for years, but today’s versions are leaning deeper into the medical field, with FDA-approved clinical features. Smartphones have also evolved with new apps that support health monitoring at home. Clinicians can leverage these tools to improve patient care by learning their functions and limitations.
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