Vitls scores 510(k) clearance for continual and remote vital signs monitoring device

The information is stored and sent to hospital systems and the Vitls app, so healthcare providers can monitor the vital signs of their patients in real-time, no matter where they are.
By Mallory Hackett
03:22 pm
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Today the remote and continuous-monitoring platform Vitls announced that it has received 510(k) clearance from the FDA.

The Vitls Platform uses a single wearable device called Tégo that records vital signs. The device itself is wireless and waterproof, and it has a battery life up to 6 days. It records body temperature, pulse, heart rate variability, respiration rate, oxygen saturation, sleep and movement. 

From there, the information is stored and sent to hospital systems and the Vitls app, so healthcare providers can monitor the vital signs of their patients in real time, no matter where they are. 

Within the Vitls app, providers get notifications whenever a patient’s vitals reach a dangerous level. It keeps track of the data collected so physicians can monitor the health trends of their patients’ vital signs. There is also a section for providers to keep notes about each of their patients.

WHY THIS MATTERS

Remote wearables that allow for continuous monitoring make up an emerging technology that can give healthcare providers a more complete picture of a patient’s status. 

A number of studies have been conducted in recent years to test the effectiveness of these types of devices in creating better patient outcomes.

One JMIR study found that post-surgical patients tended to receive antibiotics faster with continuous monitoring compared to those only getting intermittent monitoring. 

However, another BMJ study found “large discrepancies” between manual monitoring and continuous monitoring. 

Despite that, report published in Sensors concluded that the future of wearable health devices looks bright. 

“With new advances in new materials, electronics and telecommunication information technology, together with the entry of big multinational companies, such as Google, but also of small startups, WHDs are expected to overcome their challenges and enter in the consumer market with a higher impact in the following years,” the study said.

THE LARGER TREND

Remote monitoring has become particularly popular since the beginning of the COVID-19 pandemic. It allows providers to stay informed on their patients’ well-being without the risk of infection that in-person visits pose. 

In March, the FDA released a policy that expanded the use of noninvasive remote vital sign monitors until the end of the COVID-19 public health emergency. 

Following that, a number of devices entered the market. 

VitalConnect released its VitalPatch that monitors patients going through COVID-19 treatment. Royal Philips launched its Fetal and Maternal Pod and Patch that continuously monitors both the maternal heart rate and fetal heart rate, as well as uterine activity, with a dispensable electrode patch. 

ON THE RECORD

“With this FDA clearance and our US launch planned for Q3/2020, we are much closer to our goal of making continuous monitoring the standard of care in healthcare settings, as well as in the home. Healthcare needs accurate, clinical grade, continuous monitoring  especially now during COVID-19  and we’re proud and fortunate to be in a position to help,” Werner Vorster said in a statement, the CEO and founder of Vitls Inc.

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