This morning Northwestern University spinout Sibel Health landed an FDA 510(k) clearance for its patient monitoring system the ANNE One platform.
The system is able to capture a patient’s vital signs with its wearable sensors: the ANNE Limb for skin temperature and body temperature monitoring, and the ANNE Chest for heart rate, respiratory rate, step count, body position and skin temperature monitoring. Users are able to re-use and re-charge the sensors.
Sibel has also created an app that gives caregivers insights into a patient’s clinical data in real-time. The system includes a companion mobile device that is pre-loaded with ANNE. This new FDA designation is for vital sign monitoring in healthcare settings for clinical decision-making.
According to the company, before the FDA clearance the system had been deployed in a number of areas including low-resource settings. It has also been used to help assess patients with COVID-19.
WHY IT MATTERS
The company is pitching this technology as a way for clinicians to be able to monitor patient’s vital signs in real-time.
“The ability for our system to monitor a wide range of vital signs using a dual-sensor platform is very powerful and unique. The interoperability and the extendability of the system will allow us to use this approval as a foundation to expand to other novel indications and make monitoring accessible to everyone,” Jong Yoon Lee, co-founder and VP of software engineering, said in a statement.
THE LARGER TREND
Today there are many companies on the market focused on vital sign monitoring. Oxford University spinoff Oxehealth landed FDA De Novo clearance for its software that is able to estimate a pulse rate, heart rate, respiratory rate and breathing rate from a camera. Even Google has jumped into vital monitoring. In February, the company announced that Google Fit would be using a smartphone camera to log heart rate and respiratory rate.
In terms of wearable vitals monitors, last year the FDA cleared Vitls for its wireless and waterproof vital monitoring system.