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August 1, 2021FDA Updates – August 2021
August 1, 2021SEERS Bio Patch®
The SEERS Bio Patch® allows physicians to obtain vital medical information from their patients in a remote setting to provide an earlier diagnosis...
The vast growth of AI technology in healthcare cast the renovation of telehealth with the creation of medical wearable devices (a device worn on the body to collect information about a patient’s health).
Many companies have started working on advancing medical wearable technology, and one of them is the South Korean SEERS Technology, which recently launched the SEERS Bio Patch®.
The SEERS Bio Patch® is a non-invasive wireless device that monitors heart and respiratory rate, temperature, physical activity, and bioimpedance while providing an ECG – all in real-time.
With the application of this type of device in the medical practice, physicians could have the option of efficiently gathering profound, patient-specific information tailored to each patient’s demands. This information can, then, result in earlier diagnosis and higher quality medical management.
The vast growth of AI technology in healthcare cast the renovation of telehealth with the creation of medical wearable devices (a device worn on the body to collect information about a patient’s health).
Many companies have started working on advancing medical wearable technology, and one of them is the South Korean SEERS Technology, which recently launched the SEERS Bio Patch®.
The SEERS Bio Patch® is a non-invasive wireless device that monitors heart and respiratory rate, temperature, physical activity, and bioimpedance while providing an ECG – all in real-time.
With the application of this type of device in the medical practice, physicians could have the option of efficiently gathering profound, patient-specific information tailored to each patient’s demands. This information can, then, result in earlier diagnosis and higher quality medical management.
SEERS' Remote Healthcare Initiative
Over the past three decades, wearable technologies have been a part of our daily life. Incorporating artificial intelligence in wearable devices is still a developing concept; however, its application in the medical field is highly promising.
The South Korean digital healthcare company SEERS Technology was founded in 2009 to provide the global digital health market with remote patient monitoring devices integrated with artificial intelligence.(1)
The company launched the SEERS Bio Patch®, a wearable device technology that integrates information and data collected from the patient. This device is an example of the application of translational bioinformatics tools and resources in a clinical setting.(2)
About Bio Patch®
The SEERS Bio Patch® is an ambulatory, non-invasive, wireless, wearable device that can be adhered to the skin to measure a patient’s vital signs (heart rate, respiratory rate, and temperature), ECG waveforms, and bio-impedance.(2)
The Bio Patch® is to be placed on the left side of the chest similarly to an ECG electrode. A Single Lead ECG methodology (Lead II) and a temperature sensor measure different values, including Inertial Measuring Units (IMU, to substantiate physical activity), impedance, and the other variables mentioned above. It contains a heartbeat range of 30-280 beats/min.(1)
The vital signs, bioimpedance, and motion are captured by the Bio Patch® and transmitted to the iCloud via a mobile app created by the SEERS company. The app uses a multi-sensing algorithm developed to calculate the R-R intervals, QRS complexes, heart rate, heart rate variability, respiratory rate, and activity level of a patient.
The SEERS Bio Patch® is an ambulatory, non-invasive, wireless, wearable device that can be adhered to the skin to measure a patient’s vital signs (heart rate, respiratory rate, and temperature), ECG waveforms, and bio-impedance.(2)
The Bio Patch® is to be placed on the left side of the chest similarly to an ECG electrode. A Single Lead ECG methodology (Lead II) and a temperature sensor measure different values, including Inertial Measuring Units (IMU, to substantiate physical activity), impedance, and the other variables mentioned above. It contains a heartbeat range of 30-280 beats/min.(1)
The vital signs, bioimpedance, and motion are captured by the Bio Patch® and transmitted to the iCloud via a mobile app created by the SEERS company. The app uses a multi-sensing algorithm developed to calculate the R-R intervals, QRS complexes, heart rate, heart rate variability, respiratory rate, and activity level of a patient.
The information collected is then analyzed and utilized by the treating physician to provide a diagnosis and treatment plan.(3)
Advantages and Disadvantages
Some of the advantages of the SEERS Bio Patch® include its small dimensions (37mm X 29mm X 4.55mm), its low weight (9.2gr), and its long-lasting battery (A 3V Lithium coin battery with a duration of 5-7 days of continuous measurement).(2)
The Bio Patch® is made of a hypoallergenic material (hydrogen silicone) that minimizes skin irritation while maintaining adhesion. The device has an integrated sweat releasing mechanism that further extends the adhesive component lifetime. Its easy deployment also provides ambulatory cardiac monitoring capabilities at a lower cost than portable ECG monitors.(1)
A disadvantage of the SEERS Bio Patch® is the need to be placed on the chest rather than worn as an everyday aesthetic wearable technology.
Although the Bio Patch® is hypoallergenic, there is a small risk of developing skin allergies and irritation in some patients. The SEERS Bio Patch® is still not approved by the FDA; therefore, it is not available for use in the USA.
Some of the advantages of the SEERS Bio Patch® include its small dimensions (37mm X 29mm X 4.55mm), its low weight (9.2gr), and its long-lasting battery (A 3V Lithium coin battery with a duration of 5-7 days of continuous measurement).(2)
The Bio Patch® is made of a hypoallergenic material (hydrogen silicone) that minimizes skin irritation while maintaining adhesion. The device has an integrated sweat releasing mechanism that further extends the adhesive component lifetime. Its easy deployment also provides ambulatory cardiac monitoring capabilities at a lower cost than portable ECG monitors.(1)
A disadvantage of the SEERS Bio Patch® is the need to be placed on the chest rather than worn as an everyday aesthetic wearable technology.
Although the Bio Patch® is hypoallergenic, there is a small risk of developing skin allergies and irritation in some patients. The SEERS Bio Patch® is still not approved by the FDA; therefore, it is not available for use in the USA.
Influence of the SEERS Bio Patch® in the future
Nowadays, wearable devices play an essential role in assisting physicians and patients with remote tracking, identifying risk factors, remote diagnostics, and establishing effective treatments.
The current need for telehealth has brought the interest of many companies in the research and creation of new wearable devices.
With the evolution of such technology, the central monitoring system can be advantageous in understanding real-time symptoms and conditions a patient is experiencing. Thus, the better diagnostic understanding, the better therapeutics quality.
The SEERS Bio Patch® is an innovative device with many advantages and features that might help improve a patients’ quality of life. Although the FDA does not currently approve it, it provides a blueprint for other companies to create AI-driven tools with potential professional uses in the United States of America.