These Sleep Medicine Products Got FDA Nod in 2019
Sleep Review annually rounds up the sleep medicine devices, pharmaceuticals, and more that earned US Food and Drug Administration clearance.
In 2019, those included:
Released by Fisher & Paykel Healthcare Corp Ltd, the F&P Vitera features several technologies for the first time in a Fisher & Paykel full face mask, including RollFit XT, VentiCool, and VisiBlue.
WAKIX (pitolisant), a first-in-class medication marketed by Harmony Biosciences LLC, is approved for the treatment of excessive daytime sleepiness in adult patients 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.
WatchPAT 300 by Itamar Medical is a home sleep apnea diagnostic device that utilizes peripheral arterial tone and measures up to 7 channels via three points of contact. Within one-minute post study, the raw data is downloaded and auto-scored for an AHI for obstructive sleep apnea and cAHI for central sleep apnea.
WatchPAT ONE, the newest member of Itamar Medical’s WatchPAT family, offers the same simplicity, accuracy, and reliability as WatchPAT 300 but does not require a return shipment, cleaning, or charging. Through an app, the patient’s study data is securely sent to the cloud and available for interpretation as soon as the patient completes the study.
Sunosi (solriamfetol), marketed by Jazz Pharmaceuticals plc, is the first and only dual-acting dopamine and norepinephrine reuptake inhibitor approved to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea.
Neurotronics Inc introduces Neurotronics Sensors, a new line of PSG sensors. Neurotronics Sensors are designed, tested, and produced in Gainesville, Fla. They are available in multiple connector types to fit most polysomnography (PSG) systems.
Maxxi Rip Sensor by Neurovirtual is a device intended to capture respiratory effort from a patient and output the signal to a PSG device for sleep studies.
The O2Vent Optima by Oventus Medical Ltd not only provides mandibular advancement but also a proprietary airway channel that bypasses common areas of obstruction such as the nose, tongue, soft palate, and lateral walls.
ProSomnus [CA] LP by ProSomnus Sleep Technologies is a low-profile continuous advancement oral appliance for OSA. It includes standard ProSomnus appliance features as well as technologies to resolve archform asymmetries, manufacturing variances, bulkiness, and other limitations of traditional dorsal style continuous advancement devices.
The ProSomnus [PH] is a precision Herbst-style sleep device that is Medicare E0486 verified. It offers all the benefits of ProSomnus [IA] and [CA] and uses a Herbst-style advancement mechanism providing 7.0 mm total titration. It provides greater comfort, durability, and efficiency over predicate Herbst-style devices, according to a survey.
The under-the-nose nasal cradle tube-down mask is ResMed’s lightest ever. AirFit N30 joins ResMed’s Minimalist category with the full face AirFit F30 mask and pillows AirFit P10 mask.
ResMed’s tube-up pillows mask gives patients freedom to sleep in any position and fits an AirFit N30i cushion. In side-by-side comparisons conducted by ResMed, three out of four users preferred AirFit N30i over the other nasal mask with a top-of-head connection.
DROWZLE PRO by Resonea Inc is a breathing frequency monitor deployed on a mobile phone for prescreening adults with suspected obstructive sleep apnea.
The digitally designed SomnoDent Avant is SomnoMed Ltd’s slimmest oral appliance to date and its first that is milled. A durable, yet flexible nylon strap is 2 mm thick and built to preserve protrusion while limiting the mouth opening. The device works to shift the jaw in 1-mm increments.
The Transcend 365 miniCPAP is a CPAP and integrated heated humidifier capable of running on a single, travel-size battery. Marketed by Somnetics International Inc, it uses Capillary Force Vaporizer Technology, which vaporizes water using an internal element and delivers humidification to the patient during inhalation, “resting” during exhalation.
Products received FDA approval or clearance between November 1, 2018 (last year’s article cutoff) and October 31, 2019. 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 companies and available on publicly accessible websites. Sleep Review strives for accuracy in all data but cannot be held responsible for claims made by marketers. Email sroy[at]medqor.com regarding new approvals/clearances to be considered for print and online announcements.
from Sleep Review https://www.sleepreviewmag.com/sleep-diagnostics/sleep-medicine-products-fda-2019/