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Tag: FDA Breakthrough

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FDA Grants Breakthrough Device Designation to Sleep Sonar for Anatomic PSG

FDA Grants Breakthrough Device Designation to Sleep Sonar for Anatomic PSG

Bairitone Health's platform uses passive sleep sonar and a facial patch to map airway anatomy during natural sleep, aiming to pinpoint the root causes of obstruction and guide personalized therapy.

  • FDA Grants Alixorexton Breakthrough Therapy Designation for Narcolepsy Type 1

  • FDA Grants Breakthrough Designation to Inspire Medical for AHI & BMI Increase

  • FDA Grants Breakthrough Therapy Designation to Takeda’s Investigational Oral Orexin Agonist for Narcolepsy Type 1

  • Sommetrics Gets FDA Breakthrough Designation for AerSleep II for Sleep Apnea

  • Axsome’s Investigational Narcolepsy Compound Gets FDA Breakthrough Therapy Designation

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