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SleepRes earns FDA clearance for Kricket PAP device

SleepRes earns FDA clearance for Kricket PAP device

SAN FRANCISCO - SleepRes, Inc. has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Kricket PAP device, powered by Kairos Positive Airway Pressure (KPAP), for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 pounds. The SleepRes PAP system is intended for home, hospital/institutional and sleep center settings. “This milestone marks an important moment for the field of sleep medicine,” said David White, M.D., Harvard Medical School, and chief medical officer of SleepRes. “Kricket opens the door to a new category of positive airway pressure therapy that prioritizes comfort, the patient's ability to adapt, and real-world use, while still delivering the therapy patients need. That balance is critical if we want to meaningfully improve long-term outcomes for people living with obstructive sleep apnea.” The Kricket PAP device features proprietary KPAP technology, designed to dynamically adapt pressure delivery throughout the breathing cycle, rather than maintaining a constant, fixed pressure like traditional CPAP devices. By synchronizing therapy with a patient’s natural respiration and airway dynamics, KPAP aims to reduce unnecessary pressure, which may minimize discomfort, alleviate common side effects, and improve tolerance during sleep, the company says.

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