
09/05/2014
HealthSTATS is pleased to announce it has successfully obtained the following regulatory approval for the following devices effect March 2014:
U.S.Food and Drug Administration (FDA) 510k approval
1. BPro with BProSOftCASP for 24-hr ABPM and CASP monitoring
2. A-PULSE CASPal+ with Bluetooth function
3. MC3100+ BP device with Bluetooth function
CE MDD Clearance
1. A-PULSE CASPal+ with Bluetooth function
2. MC3100+ BP device with Bluetooth function
About the devices
BProSOftCASP for 24-hr ABPM and CASP monitoring provide the ability to monitor 24 hour blood pressure with the corresponding central aortic blood pressure (CASP) parameters. CASP has been found in studies to being a better predictor of cardiovascular risks.
A-PULSE CASPal+ with Bluetooth function will now provide users with the convenience of monitoring their blood pressure and CASP results via the Bluetooth communication capability.
MC3100+ BP device with Bluetooth function will now provide users with the convenience of monitoring their blood pressure results via the Bluetooth communication capability.
The Bluetooth function allows for the wireless transmission data to electronic devices and health applications.