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.
Category: Neurostimulators
Neurostimulators
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Neurostimulators
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Inspire Medical Invests in EnsoData & Ognomy
Inspire Medical Systems Inc has made equity investments in two private companies, EnsoData Inc in Wisconsin and Ognomy Inc in New York.
Neurostimulators
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FDA Grants Breakthrough Designation for Nyxoah Genio System for Obstructive Sleep Apnea & Complete Concentric Collapse
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.
EXciteOSA, Daytime Sleep Apnea Therapy Device, Surpasses 50,000 Patient Session Milestone
“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 MoreSleep Research Society Focus Group on Non-CPAP Alternatives Now Available on YouTube
Moderated 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.
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Inspire Launches Patient Experience Report
Inspire’s core objective with this report is to allow its customers to make informed decisions related to the best treatment options.
Read MoreMedicare Panel Recommends Increasing Payments for Inspire Therapy to Ambulatory Surgical Centers
CMS will review the panel’s recommendations, and the final rules will be published later in 2021.
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CPAP Alternatives: Sleep Center Personalizes Treatment for Every Sleep Apnea Patient
A flow chart from Sleep 360 Sleep Diagnostic Center illustrates the OSA patient journey from referral to customized therapy.
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Signifier Raises $35M to Accelerate Commercialization of eXciteOSA Therapy
Proceeds 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 MoreFDA Gives LivaNova Approval for Aura6000 Clinical Study for Obstructive Sleep Apnea
This 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.
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Scientists Observe Vagus Nerve Stimulation Effect on Brain Activity During Sleep & Wakefulness
Vagal-evoked potentials were largest during a specific sleep stage called nonREM sleep, during which large, slow waves dominate the electrical activity of the brain.
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How to Make Neurostimulator Acclimatization Easier for Patients
Many 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 MoreNyxoah Neurostimulator Trial Reaches Its Primary Endpoints
The trial includes a subgroup of complete concentric collapse patients who are currently contraindicated for unilateral hypoglossal nerve stimulation.
Read MoreAnthem Issues Positive Coverage Policy for Inspire Therapy
This positive coverage decision provides additional OSA patients who are unable to benefit from CPAP the opportunity to gain access to Inspire therapy.”
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New Distribution Agreement to Commercialize Inspire Therapy in Japan
Inspire 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.
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ZOLL Medical Acquires Respicardia
ZOLL, which has been a significant investor in Respicardia for more than 3 years, will welcome all Respicardia employees into its workforce.
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Signifier’s Daytime OSA Therapy Wins 2020 GOOD DESIGN Award
The 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.
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Patient with Complete Concentric Airway Collapse Achieves Control of Sleep Apnea in Nyxoah Neurostimulator Study
Currently, patients with complete concentric collapse are contraindicated for hypoglossal nerve stimulation OSA therapies.
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