Cognita Labs announced the U.S. Food and Drug Administration (FDA) has issued clearance for PulmoScan, a home-usable lung assessment device that measures airway resistance and elastance.
PulmoScan sends gentle pressure waves to identify airway blockage and stiffening walls, resulting in a simple test, requiring minimal patient effort. Its underlying oscillometry method has been studied and validated over many decades. PulmoScan can also be used at home and covered by the recently released reimbursement codes for remote patient monitoring.
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"Millions of patients don't have access to objective lung testing, even in developed countries. Our goal is to bring state of the art testing to all patients," said Mr. Patel, CEO & Cofounder of Cognita Labs. "Backed by the National Science Foundation and National Institute of Health grants, our team of leading researchers has spent years on R&D to bring PulmoScan to patients."
PulmoScan only requires rested breathing, reducing the risk, and also eliminating significant patient interaction for training. PulmoScan can be operated wirelessly from a distance, thereby further reducing operational risks.