AASM President Dr. Ilene Rosen and President-Elect Dr. Douglas Kirsch are among the sleep medicine leaders scheduled to participate in the FDA workshop, “Study Design Considerations for Devices including Digital Health Technologies for Sleep Disordered Breathing in Adults,” which will be held on April 16, 2018, from 8 a.m. to 5 p.m. at FDA’s White Oak Campus in Silver Spring, Maryland.
The topic to be discussed is the appropriate design of clinical studies to evaluate devices including digital health technologies intended for the diagnosis, monitoring, or treatment of sleep disordered breathing (SDB) in adults. Dr. Rosen will be a panelist for the session on SDB diagnosis and monitoring, and Dr. Kirsch will be the speaker for the session on current SDB digital health technologies and future trends.
Anyone interested in attending this public workshop must register by April 9, 2018, by 4 p.m. Eastern Time. Public comments related to this workshop can be submitted to the FDA by April 30. A link to the transcript of the workshop will be available after approximately 45 days.
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AASM leaders to participate in FDA workshop on devices for sleep-disordered breathing in adults
Source: Sleep Study News