Tag: New entrant

PLANO, Texas - Belluscura, a U.K. company that licenses and develops proprietary healthcare technologies, plans to launch a portable oxygen concentrator named the X-PLO2R in the U.S. market in the back half of this year.In March, Belluscura, which is headquartered in Plano, Texas, was in the middle of trying to raise funds to complete the regulatory clearance process with the U.S. Food and Drug Administration and launch the unit.“We've already raised $6 million, so it's not our only source...

SAN CLEMENTE, Calif. - The U.S. Food and Drug Administration has granted FRESCA Medical's de novo request to market its CURVE Positive Airway Pressure delivery system for the treatment of obstructive sleep apnea. “FDA clearance of the CURVE System for obstructive sleep apnea is our first step toward becoming a recognized innovator in sleep apnea,” said John Cox, president and CEO. “This market is already one of the largest applications for cloud-based patient monitoring and engagement,...