Nexalin Next-Gen Insomnia Neurostimulator Nears FDA Presentation Stage
Nexalin is planning to present its gen-2 and gen-3 to the FDA in Q1 for the treatment of anxiety and insomnia. Waveform power will be upped from 4 milliamps to 15.
Nexalin is planning to present its gen-2 and gen-3 to the FDA in Q1 for the treatment of anxiety and insomnia. Waveform power will be upped from 4 milliamps to 15.
Inspire Medical Systems Inc has made equity investments in two private companies, EnsoData Inc in Wisconsin and Ognomy Inc in New York.
The FDA will provide the Genio system with priority review and interaction with FDA’s experts throughout the premarket review phase until the product is commercialized in the United States.
“It was easy to find 20 minutes during the day to use it and the results have paid off. My husband now sleeps better without my snoring, and so do I.”
Read MoreModerated by Sairam Parthasarathy, MD, FAASM, the topic is particularly timely due to shortages of CPAP devices caused in part by the Philips CPAP/bilevel recall.
Read MoreInspire’s core objective with this report is to allow its customers to make informed decisions related to the best treatment options.
Read MoreCMS will review the panel’s recommendations, and the final rules will be published later in 2021.
Read MoreA flow chart from Sleep 360 Sleep Diagnostic Center illustrates the OSA patient journey from referral to customized therapy.
Read MoreProceeds of the financing will be directed towards commercialization of eXciteOSA in core target markets, continued development of proprietary digital patient and physician interface platforms, the generation of additional clinical data to reinforce the therapeutic efficacy of eXciteOSA, and progressing reimbursement.
Read MoreThis randomized controlled trial will take place at approximately 20 sites across the United States and will enroll a maximum of 150 adult patients with moderate to severe OSA who do not achieve results from a traditional CPAP machine or have declined its use.
Read MoreVagal-evoked potentials were largest during a specific sleep stage called nonREM sleep, during which large, slow waves dominate the electrical activity of the brain.
Read MoreMany patients give up on CPAP because they can’t tolerate the machine. Implanted neurostimulators may help, but, like positive airway pressure, these new devices can take some getting used to.
Read MoreThe trial includes a subgroup of complete concentric collapse patients who are currently contraindicated for unilateral hypoglossal nerve stimulation.
Read MoreThis positive coverage decision provides additional OSA patients who are unable to benefit from CPAP the opportunity to gain access to Inspire therapy.”
Read MoreInspire and Japan Lifeline Co Ltd worked closely with the Minister of Health Labour and Welfare to advance the reimbursement application for Inspire therapy, which was approved by an expert panel this month.
Read MoreZOLL, which has been a significant investor in Respicardia for more than 3 years, will welcome all Respicardia employees into its workforce.
Read MoreThe GOOD DESIGN award is presented by The Chicago Athenaeum Museum of Architecture and Design and The European Centre for Architecture Art Design and Urban Studies.
Read MoreCurrently, patients with complete concentric collapse are contraindicated for hypoglossal nerve stimulation OSA therapies.
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