HealthWatch seeks FDA approval for its T-shirt tracking ECG
The Israeli company HealthWatch is currently working on its new textile products. At the conference of the American Telemedicine Association in Baltimore, Maryland, the startup presented its line of hWear T-shirts with ECG (electrocardiogram) sensors woven into the fabric that allow the shirt to function as a 3-15 channel electrocardiograph .
"The cardiologist will not officially diagnose a heart attack without an ECG in 12 leads," Dr. Dov Rubin, vice president of marketing and business development at HealthWatch, said in an interview with MobiHealthNews. “If you call your cardiologist and say,“ Doctor, I have pain in my heart, ”the cardiologist, in fact, cannot do anything to help you. He will invite you to his office for inspection using a 12-channel electrocardiograph. Imagine that time is of the essence here. If you wear clothes with 12 electrodes, the data will be instantly transferred to a cardiologist, who, based on the last 10 minutes of your electrocardiogram, will be able to find out exactly what is happening. Based on this, he can diagnose a heart attack. He will refer you to the hospital and complete all the necessary procedures there. ”
T-shirts hWear can be washed and dried in a washing machine. A special electronic component is connected to a T-shirt - a unit that can store the data of the last 70 hours and transmit them wirelessly to Android smartphones. The electronic unit must be removed from the shirt before washing. According to Rubin, the shirt can be washed about 50 times without spoiling it.
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According to Rubin, the company initially provides for the use of hWear T-shirts in hospitals, in situations where long-term monitoring is necessary. The company intends to first test the product in a clinical setting before making it available to the consumer. The company is also interested in using its products in the field of remote monitoring: a T-shirt will be able to automatically alert doctors in the event of an arrhythmia or a heart attack.
Currently, the hWear T-shirt is registered with the FDA as a Class I product, but the company is seeking 510 (k) resolution for the entire system. In the future, the company is also planning to develop a version of hWear T-shirts for pregnant women, which will be used during fetal electrocardiogram.
Today, many companies at an early stage of development, focused on the development of clothing with built-in sensors. In particular, the company OMsignal , which last year raised the amount of $ 1 million. for a round of funding, working on a t-shirt with sensors woven into the fabric. The T-shirt records ECG data, activity, tracks the type of breath and the “emotional” state of the user in a continuous mode and provides all this data through the application on the user's mobile device. Although the T-shirt can track the ECG, the application does not display this information in the form of ECG data intended for doctors, since OMsignal does not seek to make an FDA-approved medical device out of its products.
At the initial stage, HealthWatch products are likely to compete with products such as the iRhythm ZIO Patch , which, according to a Scripps Institute study, is a relatively effective device.
See also: Flexible transdermal patch for monitoring EEG and ECG
If you want to be the first to learn about the latest medical and fitness gadgets, follow the company news, subscribe to our pages on social networks. You can subscribe to our blog page ,
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Facebook New gadgets and fitness devices in our online store Medgadgets.ru .
"The cardiologist will not officially diagnose a heart attack without an ECG in 12 leads," Dr. Dov Rubin, vice president of marketing and business development at HealthWatch, said in an interview with MobiHealthNews. “If you call your cardiologist and say,“ Doctor, I have pain in my heart, ”the cardiologist, in fact, cannot do anything to help you. He will invite you to his office for inspection using a 12-channel electrocardiograph. Imagine that time is of the essence here. If you wear clothes with 12 electrodes, the data will be instantly transferred to a cardiologist, who, based on the last 10 minutes of your electrocardiogram, will be able to find out exactly what is happening. Based on this, he can diagnose a heart attack. He will refer you to the hospital and complete all the necessary procedures there. ”
T-shirts hWear can be washed and dried in a washing machine. A special electronic component is connected to a T-shirt - a unit that can store the data of the last 70 hours and transmit them wirelessly to Android smartphones. The electronic unit must be removed from the shirt before washing. According to Rubin, the shirt can be washed about 50 times without spoiling it.
')
According to Rubin, the company initially provides for the use of hWear T-shirts in hospitals, in situations where long-term monitoring is necessary. The company intends to first test the product in a clinical setting before making it available to the consumer. The company is also interested in using its products in the field of remote monitoring: a T-shirt will be able to automatically alert doctors in the event of an arrhythmia or a heart attack.
Currently, the hWear T-shirt is registered with the FDA as a Class I product, but the company is seeking 510 (k) resolution for the entire system. In the future, the company is also planning to develop a version of hWear T-shirts for pregnant women, which will be used during fetal electrocardiogram.
Today, many companies at an early stage of development, focused on the development of clothing with built-in sensors. In particular, the company OMsignal , which last year raised the amount of $ 1 million. for a round of funding, working on a t-shirt with sensors woven into the fabric. The T-shirt records ECG data, activity, tracks the type of breath and the “emotional” state of the user in a continuous mode and provides all this data through the application on the user's mobile device. Although the T-shirt can track the ECG, the application does not display this information in the form of ECG data intended for doctors, since OMsignal does not seek to make an FDA-approved medical device out of its products.
At the initial stage, HealthWatch products are likely to compete with products such as the iRhythm ZIO Patch , which, according to a Scripps Institute study, is a relatively effective device.
See also: Flexible transdermal patch for monitoring EEG and ECG
If you want to be the first to learn about the latest medical and fitness gadgets, follow the company news, subscribe to our pages on social networks. You can subscribe to our blog page ,
Twitter , join our group in Vkontakte and in Facebook New gadgets and fitness devices in our online store Medgadgets.ru .Source: https://habr.com/ru/post/222213/
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