Caretaker Medical lands FDA clearance for remote blood pressure monitoring system

This morning Caretaker Medical landed FDA clearance for its blood pressure and hemodynamic patient monitoring system VitalStream. 

The tool uses a low-pressure finger sensor and wrist-worn device to monitor a patient’s blood pressure noninvasively and continuously. Using artificial intelligence to capture blood pressure and hemodynamic parameters, the tool is able to conduct “spot-check” measurements remotely. 

The system can stream patient data back to clinicians to help doctors and nurses spot deterioration. Health systems can choose how the data is streamed, whether into an EHR, mobile app, secure cloud portal or an integrated monitoring system. 


Caretaker Medical is pitching this as a way to capture more data noninvasively. Specifically, the company says the tool can be used as an alternative to A-lines and arterial catheters. 

“This is our fourth FDA clearance expanding our wireless platform and enhancing our core continuous waveform technology and artificial intelligence algorithms,” Jeff Pompeo, CEO of Caretaker Medical, said in a statement. “VitalStream sets a new standard in beat-by-beat hemodynamics in terms of accuracy, cost, simplicity of use, patient comfort and streamlined workflow. We’re delivering ICU-grade monitoring that surpasses the most stringent regulatory certifications and clinical accuracy validation requirements to help improve outcomes at all points of care.”


Blood pressure monitoring is a hot topic in the digital health world. In January, Samsung announced that it was rolling out blood pressure measurement and ECG monitoring on its consumer smartwatches. 

Swiss startup Aktiia launched in 2018 with the goal of commercializing its continuous blood pressure monitoring bracelet. In 2021, the company landed a European CE mark for its blood pressure monitoring system. 

Omron landed FDA clearance for its HealthGuide, a wearable oscillometric wrist blood pressure monitor. In June, Omron Healthcare and Kyoto University announced a joint research program to use AI and home-recorded health data to predict early signs of cardiovascular diseases. 

Even some of the tech giants may be looking to blood pressure monitoring. In September, a Wall Street Journal report said that Apple may be looking at adding blood pressure tracking to its smartwatches.

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