toSense ™ receives 510(k) clearance for the CoVa™ Monitoring System


La Jolla, CA, May 27, 2015 – toSense announced today receipt of 510(k) clearance from the Food and Drug Administration (FDA) for the CoVa™ Monitoring System (CoVa). CoVa features a novel body-worn Sensor for at-home patients with chronic illnesses, such as congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), hypertension, and renal failure. Worn like a conventional necklace for just minutes each day, the Sensor measures bioimpedance and electrocardiogram waveforms, and from these calculates thoracic impedance, heart rate, heart rate variability, and respiration rate. CoVa is designed for use in the home environment by elderly patients. Medical professionals can monitor and review data remotely. Several gateways, including Android-based tablets and cellular-based systems like Qualcomm’s 2net, forward data to the cloud. Collectively these tools allow patients to be monitored in the comfort of their own homes.

“Heart failure is the most important cause of hospital admission and readmission in the United States.” said Dr. Eric Topol, Chief Academic Officer for Scripps Health, and an advisor for toSenseTM. “This innovative necklace technology to track chest fluid status and key heart parameters has promise for use in patients with heart failure.”

“CoVa will be transformational in delivering home-health monitoring. Clinicians will have remote access to important, actionable data.” said Matt Banet, CTO at toSense. “ The system’s low price point allows universal access to a new, exciting sensor that could be a critical component of the healthcare system.”

CoVa is indicated for patients: i) with fluid-management problems; ii) taking diuretic medication; iii) living with heart failure; iv) living with end-stage renal disease; v) recovering from a coronary artery disease-related event; and/or vi) suffering from recurrent dehydration.

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About toSense

toSense is developing novel Sensors for at-home patients with chronic illnesses, such as CHF, COPD, hypertension, and renal failure. toSense is also developing consumer-friendly Sensors that make easy measurements from pre-chronic populations. Sensors currently measure thoracic bioimpedance, electrocardiogram waveforms, and other signals, and from these calculate thoracic impedance, heart rate, heart rate variability, and respiration rate. Next-generation Sensors may also calculate additional vital signs and hemodynamic parameters such as stroke volume and cardiac output and body composition.