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# De Novo Marketing Permitted for Sleep Apnea Device
- URL: https://www.fdaweb.com/de-novo-marketing-permitted-for-sleep-apnea-device/
- Published: 2018-06-27T12:00:00.000Z
- Updated: 2026-09-15T00:16:24.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141780

FDA has permitted the *de novo* marketing of Fresca Medical’s Curve Positive Airway Pressure delivery system for treating obstructive sleep apnea. The device includes a dedicated flow generator, a lightweight and ergonomic air delivery hose, and a nasal pillow patient interface. According to Fresca Medical, it features the company’s patented SmartValve technology which enables the system to treat apnea with far less airflow than conventional CPAP systems.