MATRx plus from Zephyr Sleep Technologies is an at-home sleep theragnostic that evaluates and auto-titrates for oral appliance therapy, predicting a patient’s response in advance of treatment, as well as a target therapeutic position. www.zephyrsleep.com
In the Pipeline
(The following products are likely to be FDA cleared or approved between now and mid-2019, per the developer’s guidance.)
Lemborexant is an investigational agent for sleep-wake regulation currently being studied by Eisai and Purdue Pharma for the potential treatment of multiple sleep-wake disorders. The companies have announced positive topline results from two phase 3 pivotal studies and plan to submit a new drug application for Lemborexant with the FDA in during Eisai’s 2018 fiscal year.
EnsoData‘s next major release of EnsoSleep builds on existing scoring functionality with the support of new event types and subtypes that streamline scoring workflows, further reduce the time and cost of conducting in-lab and home sleep studies, and adds advanced dashboards and analytics to provide more transparency and insight.
The next-generation Fresca PAP system offers comfort features, a small, elegant form factor, and an advanced cloud-connected technology platform. The low-airflow system is designed to eliminate the drawbacks of high-flow CPAP therapy.
Products received FDA approval or clearance between October 31, 2017, (last year’s article cutoff) and October 31, 2018. The roundup is provided as a service to sleep professionals, and marketers were not charged to have eligible products included. Text based on data submitted by marketers. Sleep Review strives for accuracy in all data but cannot be held responsible for claims made by marketers. Marketers may email sroy[at]medqor.com with a photo and description of new sleep medicine approvals/clearances to be considered for print and online announcements.