Tag: FDA Clearance

LITTLETON, Colo. - Vivos Therapeutics, a medtech company focused on developing innovative treatments for patients suffering from obstructive sleep apnea, has received clearance from the U.S. Food and Drug Administration for its proprietary daytime-nighttime (DNA) appliance. With FDA clearance, the DNA appliance offers a new treatment regimen that opens the airway by expanding the palate and training the tongue to rest in the proper position, converting patients to nasal as opposed to oral breathing. ...

LONDON — Tekcapital has announced that its portfolio company Belluscura has been granted 510(k) clearance and marketing authorization by the U.S. Food and Drug Administration for its X-PLO2R portable oxygen concentrator. "We are excited to see that the FDA has cleared the X-PLO2R device for sale, as Tekcapital and Belluscura believe it could be helpful to patients during the COVID-19 pandemic, and for many of the 250 million people worldwide suffering from COPD," said Clifford Gross, PhD, executive...

GOLETA, Calif. - Inogen has received clearance from the U.S. Food and Drug Administration (FDA) for a home oxygen concentrator called Inogen At Home. The company, better known for its portable oxygen concentrators (POCs), plans to start selling the devices later this year. “Inogen's release of the Inogen At Home, combined with its Inogen One family of products, positions the company with a complete product portfolio to be able to fulfill the clinical requirements of most oxygen therapy patients,”...