It’s been an unusual year. But, mostly as usual, the US Food & Drug Administration continued to review device and drug applications across all fields of medicine.
Text and photos by product marketers (Sleep Review does not charge marketers for inclusion)
Seamlessly integrate HSAT into your program with the Cadwell ApneaTrak. Thoughtful design includes simple setup, patient video guides, rechargeable batteries, non-proprietary connectors, and an integrated PSG software and workflow.
Eisai’s DAYVIGO (lemborexant) is an orexin receptor antagonist indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. It was approved by the FDA last December and made available in the United States in June.
NightOwl (Mini) by Ectosense is a fully disposable device that provides pAHI and total sleep time estimate. Autoscored reports are available in the free NightOwl Portal. It is smartphone connected and good for up to 14 nights on one patient.
WAKIX (pitolisant), a first-in-class medication marketed by Harmony Biosciences, is approved for the treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy. WAKIX works through a novel mechanism of action to increase the synthesis and release of histamine, a wake-promoting neurotransmitter, in the brain.
Inspire Medical Systems, maker of an obstructive sleep apnea treatment that works inside the body by restoring muscle tone in the upper airway, gained approval to treat 18-21 year old patients, as compared to the previous minimum age of 22 years old. Inspire is widely accessible for those with moderate to severe OSA who do not benefit from CPAP.
Xywav is indicated for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy. Xywav, marketed by Jazz Pharmaceuticals plc, is an oxybate product with a unique composition of cations resulting in 92% less sodium—or approximately 1,000 to 1,500 mg/night—than sodium oxybate at the recommended dosage range of 6 to 9 grams.
The Nox A1 PSG system is a multipurpose full in-lab Type I PSG system but can also perform Type II and III testing. Innovations in a number of key areas—including ergonomics, durability, scalability, and miniaturization of technology—are combined to create the next generation of PSG testing.
Somryst by Pear Therapeutics is a prescription digital therapeutic for chronic insomnia in patients 22 years of age and older that’s delivered on a mobile device. Somryst delivers cognitive behavioral therapy for insomnia over 9 weeks. Somryst was named the 2020 Best Digital Health Product Galien Prix by the Galien Foundation.
Somnera introduces a sleep apnea system that provides positive airway pressure without the continuous high airflow of CPAP. Low-flow technology eliminates the humidifier and allows the system to feature a lightweight hose—patients don’t feel attached to anything during sleep. System includes free optional support with live sleep coach.
SOMNOmedics’ most powerful, flexible sleep diagnostic device SOMNOscreen HD is now approved by the FDA for use with children. Features: Wide range of child-specific sensors, automatic sensor and electrode recognition, color touchscreen, many built-in sensors for fewer cables, wireless technology, several video options, and a pediatric scoring template.
2020 Roundup: Other New Sleep Medicine Offerings
These tools either did not require an FDA pathway or were approved previously but not available for purchase prior to January 2020.
BetterNight launched a flexible sleep health solution that lowers healthcare costs, improves outcomes, and delivers patient satisfaction.
DrLullaby provides custom family sleep plans via mobile app, alongside video coaching with doctoral-level experts.
EnsoData enhanced cybersecurity features to streamline ease of use: workflows, SSO, and IT burden.
General Sleep’s Zmachine Synergy, a Type II home sleep test, now monitors CPAP and BiPAP pressure and flow for in-home PAP studies.
Inspire Medical Systems launched a new app to help patients and physicians manage Inspire therapy.
Philips Respironics Mask Selector personalizes the mask selection/fitting process for PAP therapy via a proprietary algorithm and 3D scanning tech.
Philips launched a 2D version of Philips Respironics Mask Selector that can be used remotely from a patient’s home.
AirFit F30i is ResMed’s first tube-up full face CPAP mask, making it easier to sleep in any position.
ResMed’s AirTouch N20 is a memory foam nasal CPAP mask with easy-to-use quick-release elbow.
ResMed MaskSelector is a digital tool for HMEs that makes remote mask selection and sizing easier.
Rhythmlink’s Deep Cup EEG Electrode now has a broader rim to improve skin health for improved patient comfort and care.
SleepGlad launched a manufacturer-agnostic remote 3D PAP mask fitting solution built on artificial intelligence
SovaSage TherapistAssist Software is a manufacturer-independent OSA patient management tool enabling zero-touch PAP mask fitting and remote set up.
Products received FDA approval or clearance between November 1, 2019 and October 31, 2020. Text based on data submitted by marketers and available on publicly accessible websites. Sleep Review makes light edits to conform with editorial style. Marketers were not charged. Sleep Review strives for accuracy in all data but cannot be held responsible for claims made by marketers. Email [email protected] to be included in the next update.
