Setting its sights on the European market, yesterday California startup VivaLNK announced that it landed a Class IIa medical device CE Mark for its multi-vital medical wearable sensor and software development kit.
Researchers and clinicians can use the technology to continuously stream a patient’s ECG rhythm, respiratory rate, heart rate, RR interval and three axis acceleration.
The product includes a small reuseable patch, a wearable sensor and a SDK that lets developers build new products, according to a statement.
The company boasts that its sensors have been employed in everything from clinical trial monitoring to heart failure detection.
WHY IT MATTERS
More stakeholders are looking at wearables as a way to monitor patients, with the pharma industry in particularhas started to look into these technologies for clinical trials. However, stakeholders stress that not just any wearable will do for these trials, which means the pressure is on for validation and regulatory approval.
“There are many wearables and other gadgets that claim to be wearables for clinical trials, but there is a big difference between something that you truly use for clinical trials, to get clinical validation and real-world evidence and other wearables that are there for consumer use,” Luba Greenwood, a Harvard Lecturer and on the board of directors at MassBio, said at a MassBio event last year.
THE LARGER TREND
In 2017 VivaLnk landed FDA clearance for its first device, a peel-and-stick continuous thermometer for children called Fever Scout. Since then it has been making deals with both researchers and industry players. Last year Stanford announced it would be using VivaLNK’s Vital Scout in a study on the links between depression and stress. It also made a deal with Scottish company Current Health, which has tapped VivaLNK to bring axillary temperature and spirometry measurements capabilities to its offerings.
This fall the company announced that its remote monitoring ECG patch is available to the pharmaceutical market in order to be used for clinical trials.
ON THE RECORD
"The CE Mark is another major milestone in VivaLNK's pursuit of delivering advanced patient monitoring solutions to market. VivaLNK's unique electronic skin technology offers powerful technical capabilities without compromising user experience," Jiang Li, CEO of VivaLNK, said in a statement. "Our aim is to accelerate medical application development by providing the sensor platform so that the industry can rapidly innovate novel solutions while at the same time making it more accessible to patients around the world."