toSenseTM announced today that it recently received a second FDA clearance for its CoVaTM Monitoring System 2 (CoVaTM 2), which is now available for order. CoVaTM 2 features a body-worn sensor, wireless gateway, and cloud-based system. The recent clearance covers new measurements of stroke volume and cardiac output, which can be made at home or in medical clinics, along with display of single-lead ECG waveforms on a mobile application. CoVaTM 2 is also FDA-cleared for measurements of thoracic impedance (a proxy for fluids in the chest), heart rate, heart rate variability, respiration rate, skin temperature and posture.
Information collected by CoVaTM 2 provides medical insight into the status of patients suffering from chronic illnesses, such as congestive heart failure, chronic obstructive pulmonary disease, hypertension, and renal failure. The comprehensive supervision it provides can also reduce the time patients spend in hospitals, either by decreasing readmissions or allowing early discharge.
Worn like a conventional necklace for just minutes each day, CoVaTM 2's sensor measures bioimpedance and ECG waveforms, and from these calculates vital signs and hemodynamic parameters, as described above. The sensor sends information to several gateways, some of which can display numerics and real-time waveforms forwarding them to the cloud-based system. This system, in turn, can integrate with 3rd-party providers
"CoVaTM 2 is transformational in delivering high-acuity monitoring of both vital signs and sophisticated hemodynamic parameters outside of the hospital. The system gives clinicians remote access to important, actionable data that extends beyond conventional wearable monitors, which are limited to ECG waveforms. And its low price point and easy-to-use form factor allows universal access to a new, exciting wearable that could be a critical component of modern healthcare systems," said Matt Banet, President of toSense TM.
For more information, please visit www.toSense.com
About toSenseT
toSenseTM develops novel, wearable sensors—for patients in both the home and medical clinics—that provide critical, medical-grade information to clinicians. With this, patients can be effectively managed remotely, whether they are suffering from chronic illnesses, recently discharged from the hospital, or just waiting to see a clinician. The company strives to provide measurements of all vital signs and several hemodynamic measurements from a single location on the chest.
Media Contact
Susan Pede
VP, Operations
susan.pede@tosense.com
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