10 Kinds of Medical Wearable Devices

[Exclusive] 10 FDA-approved medical wearable devices that subvert the traditional

There is no doubt that wearable medical devices are gradually infiltrating our daily lives. According to a Mordor Intelligence report, in 2019, the market value of wearable medical devices reached 27.91 billion U.S. dollars and is expected to reach 74.03 billion U.S. dollars in 2025.

Some wearable medical devices have made major changes in the medical device industry. They can collect a lot of body data, so that users can better grasp their own health.

Nowadays, the companies that develop wearable medical devices on the market are becoming increasingly diverse. Whether it is a large technology giant or a small start-up company, they all have a place in the wearable medical device market.

The editor summarizes a list of 10 wearable medical devices approved by the FDA that have a significant impact on the medical device industry.

WHOOP

WHOOP is a wearable device full of futuristic colors. It can measure heart rate, discover heart rate changes, ambient temperature and exercise intensity to monitor athletes’ exercise intensity and physical recovery. According to the information published on the company’s website, after using the product, users will establish better sleeping habits and lifestyles, reduce resting heart rate, increase heart rate variability, and reduce injuries.

HOUGH has published many case studies and white papers on the research progress of wearable devices on behavior, heart rate variability, the link between sleep and exercise performance, and the importance of objectively measuring tension.

The company worked with Cleveland and Central Queensland University in Australia to test whether there is a link between a person’s breathing rate and the new coronary pneumonia.

Monarch external trigeminal nerve stimulation (eTNS) system

About a year ago, NeuroSigma’s research made a milestone progress. The Los Angeles, California-based company received FDA approval for the Monarch External Trigeminal Nerve Stimulation (eTNS) system, which is designed to treat attention deficit hyperactivity disorder (ADHD) in patients 7 to 12 years old. Monarch is about the size of a mobile phone. When the device is running, it generates low-level electrical pulses and connects to a small patch through a wire. The patch is attached to the patient’s forehead and above the eyebrows, which feels like a tingling sensation on the skin. The system delivers low-level electrical stimulation to the branches of the trigeminal nerve, which sends therapeutic signals to parts of the brain that are believed to be related to ADHD.

Prior to this, there were no other approved or approved technologies for the treatment of ADHD.

AliveCor’s KardiaMobile

AliveCor was the first to introduce a heart monitor (a single-channel ECG (electrocardiogram) recorder) approved by the FDA, which was previously only available through prescription in 2014. This is a major change for patients-at this time Google Glass has just come out and was initially “informally” adopted by physicians.

Although Google Glass did not arouse greater repercussions in the consumer market, AliveCor’s technology resonated with consumers. The company based in Mountain View, California eventually developed KardiaBand, a clinical-grade wearable ECG that replaced the Apple Watch strap. The company stated that the accessory provides accurate and instant analysis for detecting AFib and normal sinus rhythm in ECG. The company has also developed Kardiamobile, which is compatible with Android devices.

In April last year, KardioMobile was approved by the FDA for testing BradyCardia and TachyCardia.

Current Health’s remote patient monitoring solution

Current Health has obtained FDA approval for remote patient monitoring solutions. This wireless device can continuously and automatically monitor the patient, help to better determine the health trajectory, and help clinicians to intervene earlier. Wireless wearable medical devices can monitor respiration rate, oxygen saturation, mobility and steps, pulse rate and body temperature.

Recently, Current Health partnered with Mayo Clinic to develop a monitoring solution to accelerate the diagnosis of patients with new coronary pneumonia and predict the severity of symptoms and disease. This collaboration will use Current Health’s existing patient database-which already includes anonymous vital signs data and raw physiological sensor data from hundreds of COVID-19 patients and thousands of uninfected patients-and algorithms developed by Mayo Clinic. These algorithms will be used to provide personalized care for patients with complex and serious diseases.

Philips Biosensor BX100

Philips’ Biosensor BX100 has obtained FDA approval and CE certification. This new-generation wireless wearable biosensor can help monitor patients with new coronary pneumonia in hospitals. The Amsterdam-based company claims that its next-generation wearable medical devices can strengthen clinical monitoring and provide solutions during the monitoring process after the patient’s condition deteriorates, helping clinicians detect risks so that they can intervene early and help improve lightness. Care of patients with disease.

This lightweight disposable biosensor is a 5-day disposable wearable patch that can be integrated with an expandable hub to monitor multiple patients in multiple rooms. The device is built into the existing clinical workflow for mobile viewing and notification without cleaning or charging.

Fitbit

One of the most influential wearable devices in the medical technology field may come from an outside company-Fitbit. The company was founded in 2007 because of the huge potential of using sensors in small wearable devices. Today, 13 years later, companies and these devices have become household names-and have a profound impact and laid the foundation for future generations of wearable technology.

Recently, the company obtained the FDA’s approval and CE certification for the product to be used to assess the heart rhythm of atrial fibrillation. The application was launched on the company’s Fitbit Sense in October last year.

DexCom’s interoperable CGM

In the future, DexCom is likely to become a popular product in continuous blood glucose monitoring. The company achieved a milestone recognition in 2018, and Dexcom G6 interoperable CGM obtained FDA certification. The FDA said this is the first device it has approved for use with other compatible technologies. The FDA classifies Dexcom’s CGM as a less stringent medical device and will be able to conduct a faster review of similar systems in the future.

Dexcom G6 is a patch device about the size of a 25-cent coin. It is applied to the abdominal skin and contains a small sensor that continuously measures the glucose content in body fluids.

Provided by iRhythm iRhythm’s Zio Patch

The unique function of iRhythm Technologies is that the device integrates multiple disciplines in the field of medical technology-cardiology, artificial intelligence and wearable devices. The company is headquartered in San Francisco, California, and its Zio Patch is a wearable device that can monitor heart rate activity for up to 14 days. The company received FDA approval for the first time in 2011. This product is expected to eventually replace the Holter monitor. Holter is larger and requires battery power, which can continuously measure and record human heart activities for 24 to 48 hours or longer.

 

FreeStyle Libre rapid glucose detection system

Abbott Laboratories’ FreeStyle Libre was approved by the FDA in 2017 as a glucose monitoring system for adult blood glucose monitoring (BGM).

This approval became a hot news in the medical device industry that year, and to a large extent it is considered a great boon for American diabetic patients. With this product, patients will no longer need to use the routine that has been the standard for glucose testing for more than 40 years. Blood glucose meter.

Abbott Laboratories, headquartered in Abbott Park, Illinois, has recently received FDA approval to launch a new version of the Abbott Freestyle Libre 2 iCGM, which can be used by adults and children over 4 years old and worn for more than 14 days.

The product is worn on the back of the upper arm and measures glucose every minute to help users and their healthcare providers make more precise treatment decisions. With a one-second scan using a handheld reader, users can see their blood glucose readings, trend arrows, and eight hours of history. The product can be used with mobile applications, and Abbott is working hard to bring it to the market.

Apple’s ECG application

In 2018, Apple’s ECG application was approved by the FDA, subverting people’s traditional understanding of heart health monitoring. The fourth generation of iWathch has received a series of approvals, including an app (AFib) that can distinguish signs of atrial fibrillation, and another pure software mobile medical app for analyzing the pulse rate of irregular heart rhythms.

Although neither of these two applications are intended to replace “traditional diagnostic or treatment methods” and are not as powerful as products provided by companies such as AliveCor and iRhythm, these applications have indeed had a revolutionary impact. They make people pay more attention to cardiovascular health.

Apple successfully reignited people’s passion for wearable medical devices and put power back in the hands of consumers and patients.

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