This morning Northwestern University spin-out, Sibel Health, received FDA 510 (k) clearance for its patient monitoring system, the ANNE One platform.
The system is able to record the vital functions of a patient with its portable sensors: the ANNE Limb for monitoring skin temperature and body temperature and the ANNE Chest for monitoring heart rate, breathing rate, number of steps, body position and skin temperature. Users can reuse and rechargethe sensors.
Sibel has also developed an app that gives nurses real-time insight into a patient’s clinical data. The system includes an accompanying mobile device that has ANNE preinstalled. This new FDA approval is for the monitoring of vital signs in healthcare for clinical decision making.
According to the company, prior to FDA approval, the system was used in a number of areas, including in resource-poor environments. It has also been used to assess patients with COVID-19.
WHY IT IS IMPORTANT
The company is introducing this technology to enable clinicians to monitor patient vital signs in real time.
“The ability of our system to monitor a large number of vital parameters with a dual sensor platform is very powerful and unique. The interoperability and extensibility of the system will allow us to use this approval as a basis for expansion to other novel indications “and make monitoring available to everyone,” said Jong Yoon Lee, co-founder and VP of Software Engineering, in a statement .
THE BIGGER TREND
There are many companies in the market today that focus on vital sign monitoring. Oxford University Oxehealth landed FDA de novo approval for its software that can estimate pulse rate, heart rate, breathing rate and breathing rate from a camera. Even Google has gotten into vital surveillance. In February, the company announced that Google Fit would use a smartphone camera to track heart rate and breathing rate.
When it comes to portable vitality monitors, the FDA cleared it last year Vitls for its wireless and waterproof vital monitoring system.