FDA Clearances
Caretaker Medical’s FDA clearance of its VitalStream wireless blood pressure and hemodynamic monitoring platform
PHOTO: Caretaker Medical

FDA Clearances

Departments - Regulatory

NeuroWave Systems’ NeuroSENSE NS-901; Caretaker Medical’s FDA clearance of its VitalStream wireless blood pressure and hemodynamic monitoring

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Caretaker Medical’s FDA clearance of its VitalStream wireless blood pressure and hemodynamic monitoring platform expands the company’s clinically validated PDA waveform analysis technology and artificial intelligence (AI) to measure blood pressure and hemodynamic parameters with every heartbeat. Using a low-pressure finger sensor, VitalStream is a non-invasive alternative to A-lines and arterial catheters, enabling ICU-grade patient monitoring at all points of care to provide clinicians with streaming patient data for early indications of patient deterioration, faster life-saving interventions, and better treatment decisions.

PHOTO: Caretaker Medical

VitalStreams’s hemodynamics, waveforms, and vital sign data can be streamed remotely to the company’s mobile app or secure cloud portal, or integrated into other monitoring systems and electronic medical records (EMRs) with their FDA-cleared software interface software development kit (SDK).

 

PHOTO: NeuroWave Systems
NeuroWave Systems’ NeuroSENSE NS-901 Monitor to aid clinicians in monitoring the state of the brain in anesthetized patients (18 years of age and older). The system acquires bilateral electroencephalogram (EEG) signals and calculates bilateral Wavelet Anesthetic Value for Central Nervous System (WAVCNS) indices, one for each brain hemisphere. WAVCNS is a proprietary processed EEG parameter that quantifies the hypnotic effect of anesthetics on the brain. Powered by wavelet-based signal processing technologies tailored to EEG signals, NeuroSENSE provides immediate and delay-free tracking of changes in patient state. The monitor also provides a high-resolution bilateral density spectral array and bilateral suppression ratios.