Physiologic monitor-installed software

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Διαθέσιμο από:

Compliance Management Solutions

Kατηγορία:

Class IIa

Κατασκευάζεται από:

Biofourmis Singapore Pte Ltd 2 Venture Drive Vision Exchange, Singapore, #23-01 Singapore

Θεραπευτική περιοχή:

66625 - Physiologic monitor-installed software

Θεραπευτικές ενδείξεις:

Biofourmis Biovitals Analytics Engine is intended to be used with continuous biometric data from already cleared sensors measuring heart rate,respiratory rate, and activity in ambulatory patients being monitored in a healthcare facility or at home, during periods of minimal activity. It learns the correlation between multiple vital signs during the patient?s daily activity and builds an individualized biometric signature which is dynamically updated based on incoming data. It computes a time series Biovitals Index (BI), which reflects changes in the patient?s measured vital signs from their measured baseline, which is derived from the individualized biometric signature of the patient. It is a cloud-based software engine, intended to be an adjunct to and is not intended to replace vital signs monitoring. It is intended for review by a qualified practitioner. It is not intended for making clinical decisions regarding patient treatment or for diagnostic purposes. It is intended for an adult population.

Καθεστώς αδειοδότησης:

A

Ημερομηνία της άδειας:

2023-01-16