Tag: FDA Clearance

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,”...