The system is designated to be used by clinicians to monitor patients at home or in the healthcare setting.
Wireless healthcare technology developer LifeSignals today shared that it has received FDA 510(k) clearance for its LX1550 Multiparameter Remote Monitoring Platform.
LifeSignals’ remote patient monitoring system consists of a single-use wearable biosensor that measures electrocardiography, heart rate, respiration rate, skin temperature and body posture data for up to five days. The biosensor wirelessly transmits the encrypted data to a secure cloud-based server; the data can be viewed on the accompanying app or on the remote monitoring dashboard.
The system is designated to be used by clinicians to monitor patients at home or in the healthcare setting.
Today’s clearance follows the recent CE marking for the platform and further indicates LifeSignals’ desire to create ready-to-deploy tools for large-scale implementation.
“This FDA 510(k) approval marks another major milestone in the company’s development and mission,” Surendar Magar, founder and CEO of LifeSignals, said in a statement.
“It has already been implemented successfully in hospitals for monitoring COVID-19 patients in India and is being rolled out in Europe, UK, Singapore and the Philippines. Our focus now is to rapidly introduce low-cost remote vital sign monitoring to US healthtech companies looking to expand their services and improve patient care.”
Remote patient monitoring allows providers to monitor disease progression and detect early signs of developing conditions from afar. With the information, providers can virtually engage with patients to make adjustments to their care plans or educate them based on their vitals.
Across diseases, remote patient monitoring can reduce hospital admissions, length of stays and emergency department visits, according to BMJ Open.
The ability to remotely monitor patients became especially helpful during the pandemic amid social distancing mandates, stay-at-home orders and delayed medical visits that kept patients apart from their providers.
In fact, the increase in remote patient monitoring throughout the pandemic led experts to predict the market to double in the next five years.
With growing interest in remote monitoring, there are a number of digital health companies in the space creating tools and platforms.
Israeli wearable-tech company Biobeat recently released its cuffless continuous ambulatory blood pressure monitor. The device can measure a patient’s diastolic and systolic blood pressure, heart rate, mean arterial pressure, cardiac output and systemic vascular resistance.
In April, Donisi Health, a Tel Aviv-based maker of contactless health monitoring products, scored FDA De Novo clearance for its Gili Pro BioSensor system. It uses a combination of optical sensors and proprietary artificial intelligence algorithms to remotely monitor surface-level micro-vibrations associated with the workings of internal organs.
Remote monitoring companies are also well-funded, with Huma completing a $130 million Series C round of funding in May, TytoCare raising $50 million in March, 100plus recently scoring $25 million in seed funding, Biofourmis closing a $100 million Series C funding round last fall and Withings adding $60 million in a Series B last July.
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