Fresca Medical wins de novo nod from FDA for Curve sleep apnea device

Fresca Medical said today it won FDA de novo approval for its Curve positive airway pressure delivery system designed to treat obstructive sleep apnea. The Curve CPAP system includes a flow generator, air delivery hose and nasal pillow patient interface, the San Clemente, Calif.-based company said. The system also features the company’s SmartValve technology which it claims allows the system to treat OSA with less airflow than conventional CPAP systems. “Fresca Medical is committed to developing disruptive and effective technologies for sleep apnea sufferers who cannot tolerate the currently available therapies. FDA clearance of the Curve system for obstructive sleep apnea is our first step towards becoming a recognized innovator in sleep apnea.  Our breakthrough technology provides physicians the opportunity to offer a new breathing experience for patients who don’t want or cannot tolerate CPAP therapy. Quality sleep is fundamental to good health, and new treatment options are urgently needed in our healthcare armamentarium. This market is already one of the largest applications for cloud-based patient monitoring and engagement, and our goal is to leverage the latest connected health technology to treat, delight and engage patients and providers, while reducing healthcare costs,” prez & CEO John Cox said in a press release. Approval came based on results from a prospective, controlled, randomized, crossover, evaluator-blinded trial which showed ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Regulatory/Compliance Respiratory frescamedical Source Type: news