By Katherine Robards
In 2024, the field of sleep medicine saw continued growth, with advancements in technology, regulatory updates and new approaches to patient care. Over 20 FDA clearances for sleep devices highlighted ongoing innovation, while medications became a focal point with increasing use of GLP-1 agonists for weight loss and diabetes, development of oral medications for sleep apnea, and progress in treatments for narcolepsy and idiopathic hypersomnia. Wearables like Samsung Galaxy and Apple Watches introduced FDA-approved sleep apnea detection features, and CPAP devices evolved with lighter, more compact mask designs.
The AASM introduced several updates. A new service-based accreditation model, effective January 2025, provides more flexibility for members and programs. The AASM also launched its 2024-2027 strategic plan with a vision that emphasizes the role of sleep and circadian care in health care.
Clinical updates included a guideline for treating restless legs syndrome and periodic limb movement disorder, new protocols for the MSLT and MWT in children, and new ICD-10 codes to better reflect the distinctions of sleep-related issues. The AASM, alongside other organizations, advocated for Medicaid coverage of home sleep apnea tests.
Educational resources expanded as well. The Coding & Compliance Committee published a Remote Monitoring Services Implementation Guide, while the Emerging Technology Committee released materials on digital CBT-I platforms and insomnia technologies. The AI in Sleep Medicine Committee hosted webinars on security and privacy concerns, applications of artificial intelligence in sleep health, and more.
The year also included updates on industry recalls, developments from Philips, and activity around collaborations and acquisitions. Below, you can explore these topics and others, covering advancements in technology, regulatory changes, and emerging trends in sleep medicine. Expand each section for more details about the year’s key events.
SnoreLessNow announced that its anti-snore device, Mouth Guard+, has received FDA clearance. No prescription is required for purchase. Known as the SomnoFit-S in Europe, its patented adjustment band spans across the front teeth.
FDA authorizes app’s sleep apnea feature (Feb. 9)
Samsung Electronics announced the sleep apnea feature on the Samsung Health Monitor app has received De Novo authorization from the FDA. The feature will be available on the Galaxy Watch series in the U.S. in the third quarter of 2024.
FDA clears Masimo OTC pulse oximeter (Feb. 13)
Masimo announced that it has received FDA clearance for MightySat Medical, making it the first and only FDA-cleared medical fingertip pulse oximeter available over-the-counter (OTC) direct to consumers without a prescription.
FDA clears EnsoData pulse ox AI diagnostics (Feb. 20)
EnsoData announced it has received FDA 510(k) clearance for its technology powered by EnsoSleep PPG scoring, which enables AI-powered sleep disorder diagnosis using widely available, wearable, FDA-cleared pulse oximetry devices.
FDA clears X-trodes ‘Smart Skin’ monitoring (Feb. 20)
X-trodes announced the FDA has granted 510(k) clearance for its Smart Skin (marketed as X-trodes System M), a new wireless wearable technology for advanced electrophysiological monitoring with EEG, EOG, EMG, and EKG/ECG signals.
FDA clears SleepStageML by Beacon (March 27)
Beacon Biosignals announced it has received FDA 510(k) clearance for SleepStageML, an advanced machine learning software that automatically stages sleep from EEG signals of clinical PSG recordings to aid in diagnosis and evaluation.
Masimo receives FDA clearance for Stork baby monitoring system (May 6)
Masimo announced FDA clearance of Stork, a baby monitoring system that provides alarms to parents or other caregivers, for use with healthy babies up to 18 months of age without the need for a prescription. It monitors SpO2 and pulse rate.
FDA clears Oxevision mental health sleep monitoring (May 14)
Oxehealth announced its contactless patient monitoring platform, Oxevision, has received FDA and EU clearances for new sleep monitoring software that leverages physiological and activity data captured by an infrared sensitive camera.
FDA clears SANSA device by Huxley Medical (July 31)
Huxley Medical, a startup in the portfolio of companies at the Advanced Technology Development Center on the Georgia Tech campus, has received 510(k) clearance from the FDA for its chest-worn, sleep apnea diagnostic patch, SANSA.
FDA approves Inspire V therapy system (Aug. 2)
Inspire has announced the FDA approval of the Inspire V therapy system, which includes their next generation neurostimulator, the associated remote, and physician programmer. The company is targeting a soft launch in late 2024.
FDA clears SleepioRx for chronic insomnia (Aug. 8)
Big Health has been granted clearance by the FDA for SleepioRx, a digital therapeutic intended for the treatment of chronic insomnia as an adjunct to usual care in patients aged 18 and older. Sleepio is a prescription device delivering CBT-I.
FDA clears Masimo W1 watch connectivity (Aug. 12)
The Masimo W1 Medical watch has received FDA 510(k) clearance for connectivity, allowing it to be integrated with the Masimo SafetyNet telemonitoring solution. Last year it received FDA clearance for continuous SpO2 and pulse rate.
SoClean obtains FDA clearance (Aug. 20)
SoClean announced it has been granted De Novo clearance by the FDA for the SoClean 3+, which is to be used as an adjunct to reduce bacterial populations on certain compatible home use CPAP mask and ventilation hoses after cleaning.
FDA clears OxiWear ear pulse oximeter (Aug. 28)
OxiWear announced it has received FDA clearance for its oxygen data collection device, an ear pulse oximeter designed for continuous, real-time measurement of blood oxygen saturation (SpO2) and pulse rate across all skin types.
Withings announced the FDA has cleared its Sleep Rx Mat, which is clinically validated for use in home screening of adults with suspected sleep-disordered breathing as an aid for diagnosis of OSA, sleep analysis, and heart rate estimation.
FDA clears Apple sleep apnea notification (Sept. 16)
FDA has cleared the sleep apnea notification feature of the Apple Watch as an “over-the-counter device to assess risk of sleep apnea.” FDA notes, “It is not intended to provide a standalone diagnosis” or “replace traditional methods of diagnosis.”
FDA clears Vivos oral appliance for children (Sept. 19)
Vivos Therapeutics announced its DNA appliance, part of its CARE line of OSA treatment appliances, has received FDA clearance to treat moderate to severe OSA and snoring in children. It’s intended for those who also require orthodontic treatment.
FDA clears Happy Ring by Happy Health (Oct. 8)
Happy Health has received FDA clearance for its Happy Ring, which monitors health metrics such as sleep, blood oxygen, heart rate, activity, temperature, and brain activity. Its first clinical program, Happy Sleep, will launch later this year.
FDA clears pulse ox in EvieMED Ring (Dec. 2)
Movano Health announced FDA 510(k) clearance for the pulse oximeter in its EvieMED Ring. In addition to measuring SpO2 and heart rate, the ring collects metrics including sleep, activity, temperature, calories burned, and respiration rate.
Takeda will initiate Phase 3 trials after positive results from a randomized, double-blind, placebo-controlled, multiple dose Phase 2b trial evaluating TAK-861, an oral orexin receptor 2 agonist, in patients with narcolepsy type 1.
Lilly addresses use of weight loss drugs (March 7)
Lilly addressed certain practices relating to its tirzepatide medicines (Mounjaro and Zepbound) to ensure they are prescribed and used safely, noting they should not be used for cosmetic weight loss or in patients under the age of 18.
Axsome presents new narcolepsy drug data (March 25)
Axsome Therapeutics announced that AXS-12 (reboxetine) achieved the primary endpoint and significantly reduced the frequency of cataplexy attacks compared with placebo in patients with narcolepsy in a Phase 3 multicenter trial.
Zevra announces top-line data from Phase 2 clinical trial of KP1077 for idiopathic hypersomnia (March 26)
Zevra Therapeutics announced top-line data from its placebo-controlled, double-blind Phase 2 clinical trial evaluating the safety and tolerability of KP1077 (serdexmethylphenidate) in patients with idiopathic hypersomnia.
Alkermes announces results from phase 1b study of ALKS 2680 in narcolepsy, idiopathic hypersomnia (April 9)
Alkermes announced positive topline results from a phase 1b, proof-of-concept study evaluating ALKS 2680, the company’s novel, investigational, oral orexin 2 receptor agonist in development as a once daily treatment for narcolepsy.
Harmony licenses new narcolepsy drug (April 11)
Harmony Biosciences announced an exclusive licensing agreement with Bioprojet to commercialize TPM-1116, a selective oral orexin-2 receptor agonist that will be evaluated for the treatment of narcolepsy and other sleep disorders.
Tirzepatide reduced OSA severity by up to nearly two-thirds in adults with obesity (April 17)
Eli Lilly announced positive topline results of phase 3 clinical trials showing the injectable prescription drug Zepbound (tirzepatide) significantly reduced the AHI compared to placebo in adults with moderate to severe OSA and obesity.
Alkermes announces initiation of Vibrance-1 phase 2 study evaluating ALKS 2680 for Narcolepsy type 1 (April 24)
Alkermes announced initiation of the Vibrance-1 study, a phase 2 clinical trial evaluating the safety and efficacy of ALKS 2680, a novel oral orexin 2 receptor agonist in development as a once daily treatment for narcolepsy type 1.
Johnson & Johnson study of seltorexant shows improvement in depressive symptoms, sleep disturbance (May 29)
Johnson & Johnson announced positive results from a Phase 3 clinical trial exploring the efficacy and safety of seltorexant as an adjunctive treatment to antidepressants in adults with major depressive disorder with insomnia symptoms.
Incannex makes progress in OSA drug trial (May 30)
Incannex Healthcare announced that patient dosing has commenced in the company’s Phase 2/3 clinical trial to assess safety and efficacy in patients with sleep apnea of IHL-42X, which combines low-dose dronabinol and acetazolamide.
What GLP-1 data could mean for OSA (June)
In this online update, ResMed Chief Medical Officer Carlos Nunez takes a closer look at what the latest GLP-1 data could mean for those with OSA, and he describes how combo therapy with medication plus CPAP may be optimal for treatment.
Zevra shares positive results for idiopathic hypersomnia drug (June 3)
At SLEEP in Houston, Zevra Therapeutics presented final positive results from its placebo controlled, double blind Phase 2 clinical trial evaluating the safety and tolerability of KP1077 (SDX) in patients with idiopathic hypersomnia.
Takeda presents results for narcolepsy drug (June 3)
Takeda presented positive results from its Phase 2b trial of TAK-861 in narcolepsy type 1 as late-breaking data presentations at the SLEEP 2024 meeting in Houston. TAK-861 is an investigational oral orexin receptor 2 agonist.
Alkermes shares data from narcolepsy study (June 3)
Alkermes announced data from the narcolepsy type 1 cohort of a phase 1b, proof-of-concept study evaluating ALKS 2680, a novel, investigational, oral orexin 2 receptor agonist in development as a once daily treatment for narcolepsy.
Harmony presents data on Wakix for excessive daytime sleepiness in DM1 (June 5)
At SLEEP 2024 in Houston, Harmony Biosciences presented data from its Phase 2 signal detection study showing that Wakix (pitolisant) reduced excessive daytime sleepiness and fatigue in adults with Myotonic dystrophy Type 1 (DM1).
Tirzepatide for OSA and obesity (June 21)
A study published in the New England Journal of Medicine involved two phase 3, double-blind, randomized, controlled trials of tirzepatide in adults with moderate to severe OSA and obesity. Treatment reduced the AHI and body weight.
Lilly anticipates FDA action on tirzepatide (June 21)
Eli Lilly has submitted tirzepatide for the treatment of moderate-to-severe OSA and obesity to the FDA, and the company anticipates regulatory action as early as the end of this year based on the Fast Track designation it already received.
FDA approves Wakix for pediatric narcolepsy (June 24)
Harmony Biosciences announced that the FDA has approved its supplemental new drug application for Wakix (pitolisant) tablets for the treatment of excessive daytime sleepiness in pediatric patients 6 years of age and older with narcolepsy.
Study compares GLP-1 weight loss drugs semaglutide and tirzepatide (July 8)
A cohort study of 18,386 matched patients found use of tirzepatide was associated with significantly greater weight loss than semaglutide in adults who are overweight or obese, according to a new study published in JAMA Internal Medicine.
Pfizer advances development of once-daily formulation of oral GLP-1 receptor agonist danuglipron (July 11)
Pfizer announced that based on results from the ongoing pharmacokinetic study, the company has selected its preferred once-daily modified release formulation for danuglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist for obesity.
Roche announced positive topline results from two arms of an ongoing multi-part Phase I clinical trial for CT-996, an investigational, once-daily, oral small molecule GLP-1 receptor agonist being developed for the treatment of both type 2 diabetes and obesity.
First patient dosed in Lumryz trial for idiopathic hypersomnia (July 31)
Avadel Pharmaceuticals announced that the first patient has been dosed in REVITALYZ, a multicenter phase 3 study evaluating Lumryz (sodium oxybate) given once at bedtime as a potential treatment for idiopathic hypersomnia in adults.
Avadel reports weight loss with Lumryz (Aug. 20)
Avadel announced the publication of results of a post-hoc analysis from the completed pivotal phase 3 REST-ON clinical trial demonstrating greater weight loss in patients with narcolepsy who received Lumryz (sodium oxybate) compared with placebo.
Alkermes announces Vibrance-2 phase 2 study evaluating ALKS 2680 for treatment of narcolepsy (Aug. 22)
Alkermes announced the initiation of the Vibrance-2 study, a phase 2 clinical trial evaluating the safety and efficacy of ALKS 2680 — a novel, once-daily, oral, selective orexin 2 receptor agonist — in adults with narcolepsy type 2.
Avadel announces Lumryz study results (Sept. 3)
Avadel announced the publication of final data from the RESTORE open-label switch study, demonstrating people with narcolepsy prefer once-at-bedtime Lumryz versus a twice-nightly immediate-release oxybate treatment option.
Patients show interest in switching to a pill for OSA (Sept. 9)
Quantum Research Group announced the results of a new survey, “Understanding Obstructive Sleep Apnea Treatment Experiences and Patient Perspectives,” finding that 69 percent of patients with OSA are willing to switch to a pill-form treatment. The survey was commissioned by Incannex.
Sulthiame reduces OSA severity (Sept. 10)
Patients taking sulthiame, a drug currently in use for epilepsy, experienced a reduction in their symptoms of OSA, according to results of a clinical trial. Sulthiame inhibits the enzyme carbonic anhydrase and stimulates the upper airway muscles.
Apnimed announces early completion of enrollment in phase 3 SynAIRgy study (Sept. 19)
Apnimed announced the early completion of enrollment in its SynAIRgy Phase 3 Study, which will examine the efficacy and safety of AD109 (aroxybutynin / atomoxetine) compared to placebo at six months in adults living with OSA.
Avadel announces Lumryz clinical trial results (Sept. 25)
Avadel Pharmaceuticals announced publication of clinical trial results showing significant improvements in patients with narcolepsy taking Lumryz (sodium oxybate) compared with placebo, regardless of concomitant use of alerting agents.
FDA approves Lumryz for pediatric narcolepsy (Oct. 17)
Avadel Pharmaceuticals announced the FDA has approved its supplemental new drug application for Lumryz (sodium oxybate) for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy.
Jazz presents new Xywav trial data (Oct. 31)
At Psych Congress 2024, Jazz Pharmaceuticals presented the top-line results of the Phase 4 DUET trial, evaluating the effectiveness of low-sodium oxybate on key sleep outcomes in adults with narcolepsy or idiopathic hypersomnia.
Alkermes presents data on ALKS 2680 (Nov. 7)
Alkermes presented safety and efficacy data on ALKS 2680, a novel, investigational oral medicine in development as a once daily treatment for narcolepsy and idiopathic hypersomnia, at two scientific conferences this fall.
Combo drug therapy for sleep apnea (Nov. 16)
A study in the Annals of the ATS reports short-term use of dual drugs acetazolamide + eszopiclone substantially improved OSA severity. Adding venlafaxine did not generally improve OSA severity but may be beneficial for some patients.
Solriamfetol improves cognitive function (Nov. 16)
A randomized phase 4 clinical trial published in CHEST found that solriamfetol can improve objective and subjective measures of cognitive function in patients with cognitive impairment associated with OSA and excessive daytime sleepiness.
AXS-12 demonstrates cataplexy improvement (Nov. 26)
Axsome Therapeutics announced that AXS-12 (reboxetine) achieved the primary endpoint in the ENCORE phase 3 trial in narcolepsy, showing a statistically significant improvement in cataplexy attack frequency compared to placebo.
ResMed announced the launch of its AirCurve 11 series, the company’s newest bilevel PAP devices. AirCurve 11 devices are built on ResMed’s AirSense 11 platform, are compatible with all ResMed masks, and are available in the U.S.
ProSomnus appliance has an oximeter (Feb. 22)
ProSomnus announced results of its pilot study for the company’s next generation remote patient monitoring (RPM) device for OSA, demonstrating that an oximeter embedded in an oral appliance can accurately and safely monitor SpO2.
Samsung unveils new Galaxy Ring (Feb. 26)
Samsung unveiled its new Galaxy Ring at the Mobile World Congress 2024 meeting in Barcelona. The ring, which will be released later this year, will track sleep based on heart rate, movement, and breathing, then provide users advice.
ResMed introduces AirFit F40 mask (March 6)
ResMed announced the U.S. launch of the AirFit F40, an ultra-compact, lower-profile, full-face mask that offers the comfort of smaller masks without sacrificing performance in order to help improve sleep apnea therapy adherence.
React Health launches Luna TravelPAP (March 8)
The new Luna TravelPAP from React Health is a small and lightweight PAP therapy device that weighs only 14 ounces and has an optional 12V DC car adapter, giving you the freedom to get a good night’s sleep no matter where you go.
Blood test can detect sleep deprivation (March 11)
A blood test that can accurately detect when someone has not slept for 24 hours has been developed at University of Birmingham and Monash University. The biomarker used a combination of markers found in the blood of healthy volunteers.
Nasal spray reduces sleep apnea severity (March 15)
A new potassium channel blocker nasal spray reduces sleep apnea severity and lowers blood pressure the next morning in those who have physiological improvement in upper airway collapsibility, reports a small study of 10 people with OSA.
Fisher & Paykel Healthcare unveils its smallest and lightest mask yet with the F&P Nova Micro (April 9)
Fisher & Paykel Healthcare announced the launch of the compact F&P Nova Micro nasal pillows mask, which weighs only 1.4 ounces. It is available in New Zealand, and sales in Australia, Europe and the U.S. will follow later this year.
Redesigned Sleep experience now in the Fitbit app (April 10)
Fitbit announced it has redesigned the Fitbit app to make it easier to track sleep patterns. The app now features a simpler navigation, provides detailed sleep timeline insights, and enables users to see their sleep patterns over time.
Fisher & Paykel Healthcare launches revolutionary F&P Solo Nasal mask for OSA in the U.S. (April 16)
Fisher & Paykel announced the launch of the F&P Solo Nasal mask in the U.S. The world’s first “AutoFit” mask, F&P Solo simplifies treatment setup by enabling users to stretch the mask onto their face and adjust it with just one touch.
UC researchers develop new CPAP device (April 17)
University of Cincinnati researchers are developing a VortexPAP machine that takes advantage of vortex airflow technology to deliver the pressure levels that are used in CPAP therapy, but with a mask that is more comfortable to wear.
Glidewell launches digital Silent Nite 3D-printed appliance (May 1)
Glidewell is now offering the Silent Nite 3D Sleep Appliance, a fully digital, 3D-printed sleep appliance for prescription by dental professionals. The mandibular advancement device is fabricated from durable, light-cured resin.
Somnee sleep wearable launches new app to evaluate sleep quality and readiness more deeply (May 14)
Somnee, maker of a smart sleep EEG therapeutic stimulation headband, announced its revamped app experience and new features such as brain mapping and sleep readiness scores, providing a novel dimension of sleep data to its users.
Fullpower-AI launches Sleeptracker-AI, empowering health care with the world’s largest sleep dataset (May 28)
Fullpower-AI announced the launch of the Sleeptracker.ai platform, which has more than 250 million nights of high-fidelity sleep data. The Sleeptracker-AI system is noninvasive and contactless, allowing long-term data collection.
Nox Medical introduces Nox Connect cloud-based platform to streamline sleep lab operations (May 28)
Nox Medical announced the launch of Nox Connect, a cloud-based platform that enhances the way sleep labs manage sleep testing and personnel operational workflows by connecting Nox devices, data, and diagnostics on one cloud platform.
Blood test can help predict risk of obstructive sleep apnea (July 1)
A new study reports that measuring the level in the blood of the amino acid homocysteine can help predict a person’s risk of developing OSA, and this blood test can help clinicians gauge whether a patient is likely to develop severe OSA.
Masimo announces Sleep Halo, advanced sleep analysis for the Masimo W1 (July 1)
Masimo announced that the Masimo W1 Sport advanced health tracking wearable is gaining sleep analysis with Sleep Halo, which uses continuous pulse oximetry and machine learning to provide meaningful sleep insights.
New Samsung Galaxy Ring and Galaxy Watch focus on sleep (July 10)
Samsung Electronics announced the new Galaxy Ring, Galaxy Watch7 (with an FDA authorized sleep apnea feature) and Galaxy Watch Ultra are now available for pre-order. Galaxy Ring features Samsung’s sleep analysis and a sleep AI algorithm.
SoundHealth raises $7 million, launches FDA-authorized, AI-enabled wearable for nasal congestion (July 24)
SoundHealth introduced Sonu, the world’s first FDA De Novo authorized, AI-enabled, wearable medical device for the treatment of moderate to severe nasal congestion due to allergic and non-allergic rhinitis for at-home use by individuals 22 years of age and older.
A new study using Fitbit data uncovers connections between sleep and disease (July 24)
A new study was based on nearly 6.5 million nights of sleep from over 6,700 Fitbit users participating in the All of Us Research Program collected over an average of 4.5 years. The research looks at links between sleep and human disease.
ReactDx launches NiteWatch HSAT device (Aug. 1)
ReactDx announced the launch of NiteWatch, an FDA-cleared home sleep apnea test device that measures six channels: SpO2, PPG, pulse rate, airflow, respiratory effort, and heart rate variability. It also integrates with a mobile app for seamless data transmission.
Dozing at the wheel? Not with these fatigue-detecting earbuds (Aug. 5)
To protect drivers and machine operators from the dangers of drowsiness, engineers at the University of California, Berkeley, have created prototype earbuds that can detect the signs of drowsiness in the brain in the same way as EEG.
Study compares Galaxy Watch to PSG (Sept. 1)
A study in the Journal of Clinical Sleep Medicine found that the Samsung Galaxy Watch 4 conducted reliable overnight continuous SpO2 monitoring and demonstrated excellent to outstanding discrimination for OSA identification and severity.
Apple Watch Series 10 features sleep apnea notifications (Sept. 10)
Apple unveiled Apple Watch Series 10, which helps identify signs of sleep apnea by monitoring small movements at the wrist that are associated with interruptions in normal respiratory patterns. Apple expects FDA clearance soon.
ResMed introduces its first fabric mask (Sept. 30)
ResMed announced the launch of the fabric-wrapped AirTouch N30i mask and other patient products including the myAir smartwatch app, new sleep stages and health trends data for myAir, and new LUXE totes and backpacks for CPAP users.
ŌURA releases new Oura Ring 4 (Oct. 3)
ŌURA announced the release of Oura Ring 4, which is powered by recessed, research-grade sensors that deliver improved signal quality for blood oxygen sensing, a more accurate breathing disturbance index, and up to eight days of battery life.
Neurovalens launches Modius Sleep (Oct. 28)
Neurovalens has launched Modius Sleep to treat chronic insomnia. Modius Sleep is an FDA-cleared, physician-prescribed medical device worn on the head for 30 minutes each evening. It sends an electrical pulse into the vestibular nerve.
New consumer and clinical sleep tech (Nov. 16)
The #SleepTechnology resource, for AASM members only, has been updated and has more than 180 assessments of novel sleep devices and apps. View new info about tech such as Oxevision, Soltec System, and CentrePoint Insight Watch.
LivaNova provides clinical study update (Nov. 11)
LivaNova announced that its OSPREY randomized controlled trial met its primary endpoints for the aura6000, an implantable hypoglossal neurostimulator intended to treat adult patients with moderate to severe obstructive sleep apnea.
F&P launches smallest mask, Nova Micro (Nov. 12)
Fisher & Paykel Healthcare announced the U.S. launch of the F&P Nova Micro nasal pillows mask for the treatment of obstructive sleep apnea. Weighing less than 1.4 ounces, the compact Nova Micro is F&P’s smallest and lightest mask yet.
Galaxy Watch update expands sleep features (Nov. 19)
Samsung’s One UI 6 Watch update is rolling out to more Galaxy devices, offering advanced AI-powered sleep metrics and the De Novo FDA-authorized sleep apnea detection, now available across a wider range of Galaxy Watch models.
In 2024, we’ll see artificial intelligence technology move from experimenting and trial to real-world use cases, especially in areas that reduce administrative burdens, help clinicians easily find information, assist healthcare call center agents, and ultimately help organizations run more efficiently.
Mount Sinai researchers have been awarded a five-year, $4.1 million grant from the National Heart, Lung, and Blood Institute at the National Institutes of Health to develop and study an artificial intelligence (AI)-powered model that predicts adverse outcomes of obstructive sleep apnea.
Technology experts, general public forecast impact of artificial intelligence (Feb. 29)
Technology experts and the U.S. public share serious concerns about the future of privacy, job opportunities, politics and democracy, civility and many other aspects of life, according to a new report from Elon University, “The Impact of Artificial Intelligence by 2040.”
Mount Sinai researchers to develop AI-powered models that identify heart risks in patients with OSA (March 7)
Mount Sinai researchers are developing and studying models powered by artificial intelligence (AI) to identify the risk of cardiovascular disease events in patients with obstructive sleep apnea. The prediction models, using machine-learning techniques, will also help classify patients who may benefit from the most common treatment option for the disorder.
Artificial intelligence & medical products (March 22)
This paper describes four areas of focus for the FDA’s Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, and Office of Combination Products regarding the development and use of AI across the medical product life cycle.
Using AI-enabled tech in sleep medicine (March 27)
An article in JCSM by the AASM Artificial Intelligence in Sleep Medicine Committee describes the scope of AI technology in sleep medicine and outlines potential uses in clinical care, lifestyle management and population health management.
Findings shed light on risks and benefits of integrating AI into medical decision-making (July 23)
Researchers at the National Institutes of Health found an artificial intelligence model solved medical quiz questions with high accuracy. However, physician graders found the AI model made mistakes when describing images and explaining how its decision-making led to the correct answer.
UMass Amherst researcher to use wearable sleep trackers, AI to predict early signs of Alzheimer’s (Sept. 12)
The National Institutes of Health has awarded Joyita Dutta, professor of biomedical engineering at the University of Massachusetts Amherst, $3.9 million over five years to study if wearable sleep trackers can predict blood biomarkers of Alzheimer’s disease in at-risk individuals.
New JCSM artificial intelligence collection (Nov. 9)
Now on the JCSM website is a collection of papers relevant to the integration of artificial intelligence in sleep medicine. Topics include guidance and education, assisted decision making, automated sleep scoring, and patient education.
AI facial scans help detect sleep disorders (Nov. 19)
A study by sleep researchers at Stanford University, in collaboration with SoundHealth Inc., explores how smartphone facial scans powered by artificial intelligence can analyze facial structures linked to sleep disorders like insomnia and OSA.
Sleep diagnostics company Sunrise has acquired digital sleep clinic Dreem Health, which offers convenient access to sleep care through its telemedicine platform, which is covered by insurers such as Aetna and United Healthcare.
Circadiance partners with MaskFit AR (March 4)
Circadiance’s SleepWeaver masks are now on the MaskFit AR formulary and Fit Checker, a mask fit tool driven by artificial intelligence that helps patients find the perfect fit and discover alternative masks for their facial features.
Medixine and Nonin Medical join forces (April 23)
Finnish company Medixine announced a partnership to combine its digital remote patient monitoring software platform with Nonin Medical’s pulse oximetry devices to improve care delivery such as overnight assessment during sleep.
EnsoData announced a collaboration with the Parachute Health platform, the largest integrated DME marketplace, to introduce an efficient, collaborative workflow that ensures patients quickly receive treatment for sleep apnea.
EnsoData announced the acquisition of sleep testing diagnostic technology from Resonea, adding two new channels to its platform — an acoustic flow channel and a microphone channel — to enable a new way to pre-screen patients for sleep apnea.
Cosette Pharmaceuticals acquires Ambien and Ambien CR tabs from Sanofi in the US market (July 10)
Cosette Pharmaceuticals has completed the acquisition of Ambien and Ambien CR in the United States from Sanofi US.
Beacon Biosignals announces strategic collaboration with Skye Bioscience (July 24)
Beacon Biosignals announced a strategic collaboration with Skye Bioscience, a pharmaceutical company focused on unlocking new therapeutic pathways for metabolic health, to enhance its upcoming CBEYOND Phase 2 clinical trial of Nimacimab. This partnership will incorporate sleep quality and sleep apnea endpoints via the Beacon Platform and the FDA 510(k)-cleared Dreem 3S EEG device to better understand the comprehensive impact of Nimacimab on patients with obesity.
EnsoData, Nonin partner to offer affordable, non-invasive at home sleep testing (Aug. 13)
EnsoData and Nonin, a leader in pulse oximetry devices, announced a partnership to combine the recently FDA-cleared EnsoSleep PPG software as a medical device algorithm with Nonin’s WristOx2 Model 3150 reusable wrist-worn device.
Happy Health partners with EnsoData (Oct. 31)
EnsoData and Happy Health, makers of the Happy Ring, announced a partnership to simplify at-home sleep apnea diagnosis and treatment monitoring. EnsoSleep PPG will expand the diagnostic capability of Happy Ring sleep data.
HME news reports that Philips filed a counter lawsuit on Jan. 5 against SoClean and its private equity owner, DWHP, arguing they “recklessly and unlawfully” marketed their ozone cleaning devices as compatible with its PAP devices.
Philips discontinues some sleep devices (Jan. 26)
Philips announced it is discontinuing some sleep devices including the Alice 6 diagnostic machine, DreamStation Go portable PAP, NightBalance positional therapy, OmniLab Advanced + titration system, and Trilogy Evo ventilator.
Philips agrees on terms with the DOJ (Jan. 29)
Philips announced on Jan. 29 it has agreed on terms of a consent decree with the DOJ, representing the FDA. In the U.S., Philips will stop selling new PAP devices and other respiratory care devices until relevant requirements are met.
Philips recall: FDA medical device reports (Jan. 31)
A Jan. 31 update indicates that since April 2021, FDA has received more than 116,000 medical device reports, including 561 reports of death, reportedly associated with foam breakdown or suspected foam breakdown in Philips PAP devices.
Questions on future of Philips Respironics (Feb. 5)
The Pittsburgh Post-Gazette explored the uncertainty surrounding the future of Philips Respironics, the largest medical device maker in the Western Pennsylvania region, following a new consent decree announced by Royal Philips.
Watch: Adapting to Philips product changes (March 25)
On YouTube you can watch the AASM video recording of the recent multi-society webinar featuring a panel discussion about the announcement by Philips Respironics that it is discontinuing various sleep and respiratory care devices in the U.S.
Philips Respironics reaches agreement with FDA and DOJ (April 11)
Philips announced it has reached a final agreement with the FDA and Department of Justice on a consent decree, focusing primarily on Philips Respironics’ business operations in the U.S. The consent decree must be approved by a judge.
Philips resolves personal injury and medical monitoring litigation in the US for 1.1 billion (April 29)
Philips Respironics has agreed to pay $1.1 billion to resolve the personal injury litigation and medical monitoring class action in the U.S. Payments are expected in 2025. Philips and Philips Respironics do not admit fault or liability.
Philips sues SoClean in federal court (May 13)
Philips is suing SoClean, maker of ozone-based cleaning systems for breathing devices, in an effort to make it pay part of a $1.1 billion settlement Philips reached last month with people who say they were injured by Philips devices.
Philips warns of interruptions and/or loss of therapy due to ventilation inoperative alarm (May 28)
FDA announced Philips is updating the use instructions for its OmniLab Advanced+ ventilator and its BiPAP V30, A30, and A40 ventilators due to a failure in the “ventilator inoperative” alarm, which can cause therapy interruption or loss.
Inside the Philips PAP device recall: Internal fights and resignations (July 7)
Documents obtained by the Pittsburgh Post-Gazette reveal that nearly a dozen Philips engineers and other employees pushed the company to warn patients about the dangers of its PAP device foam long before Philips announced a recall.
Impact of Philips leaving the US market (Aug. 1)
An article in the August issue of JCSM examines the impact of the announcement by Philips that it will no longer manufacture or sell hospital ventilation products, home ventilation devices, oxygen concentrators, and sleep diagnostic devices.
Philips sets deadline to register PAP devices (Aug. 8)
Philips announced it will no longer accept new registrations in the U.S. after Dec. 31, 2024, for CPAP and BiPAP devices affected by its recall. As of July 3, it has received 2.65 million actionable registrations of sleep therapy devices in the U.S.
FDA classifies ResMed mask recall (Jan. 19)
The FDA has identified the ResMed recall of CPAP masks with magnets as a Class I recall, the most serious type, due to possible magnetic interference with certain medical implants and devices. There have been six reported injuries.
Sleepnet recalls PAP masks with magnets (March 18)
Sleepnet Corporation has initiated a worldwide recall for all PAP masks with magnets due to potential interference with certain medical implants or metallic implants. Affected products include the Mojo, iQ 2, and Phantom 2 PAP masks.
Fisher & Paykel Healthcare initiates voluntary limited recall of Airvo 2 and myAirvo 2 devices (March 28)
Fisher & Paykel Healthcare has initiated a voluntary, limited recall of batches of Airvo 2 and myAirvo 2 high flow therapy devices manufactured before Aug. 14, 2017, due to a speaker issue that may affect the sound levels of the alarm.
FDA has identified a Philips recall of Trilogy Evo ventilators as a Class I recall, which is the most serious type. Philips is providing a software update to address a possible power malfunction that can result in sudden loss of ventilation.
Fisher-Price recalls infant Snuga Swings (Oct. 10)
The U.S. Consumer Product Safety Commission and Fisher-Price announced the recall of Snuga Swings. Between 2012 and 2022, there were five reports of deaths involving infants 1 to 3 months of age when the product was used for sleep.
CMS finalizes prior authorization rule (Jan. 17)
CMS has released its prior authorization final rule. Beginning primarily in 2026, impacted payers will have to send prior authorization decisions within 72 hours for expedited requests and 7 calendar days for standard requests.
Biden cracks down on prior authorization — but there are limits (Jan. 18)
More than a year after it was initially proposed, the Biden administration announced a final rule that will change how insurers in federal programs such as Medicare Advantage use prior authorization — a long-standing system that prevents many patients from accessing doctor-recommended care.
Other states should follow New Jersey’s lead on prior authorization reform (Jan. 25)
After Washington in 2023, New Jersey just became the second state to pass legislation that reforms prior authorization for state-regulated health plans.
More than 40 prior authorizations a week is way too many (April 29)
According to the AMA, the time-wasting, care-delaying, insurance company cost-control process known as prior authorization has gone from a rarely employed tool to discourage use of extremely pricey interventions to a form of utilization management that comes as naturally to payers as breathing does to the rest of us.
Necessity is the mother of claim denials (May)
Kodiak reports that the prior authorization or precertification claim denial rate, expressed as a percentage of all claim dollars billed, has risen in each of the past two years. It rose from 1.35% in 2021 to 1.65% in 2023, an increase of 22%.
Bill proposes to reform prior authorization (June 12)
A bipartisan group of senators has reintroduced in Congress the “Improving Seniors’ Timely Access to Care Act,” which is supported by AASM. It would reduce burdens by streamlining the prior authorization process under Medicare Advantage.
After falling short last Congress, prior authorization bill primed for passage (June 12)
With the American Medical Association’s backing, members of the House and Senate introduced bipartisan legislation to streamline and standardize the use of prior authorization within Medicare Advantage, building on its widespread support in the last Congress.
Use of prior authorization in Medicare Advantage exceeded 46 million requests in 2022 (Aug. 8)
A new report indicates that there were 1.7 prior authorization requests per Medicare Advantage enrollee in 2022, and insurers fully or partially denied 7.4% (3.4 million) of requests, up from 5.8% in 2021.
AMA: Over 80% of prior authorization appeals succeed. Why aren’t there more? (Oct. 3)
The overwhelming majority of prior authorization appeals — 83.2% — resulted in the insurance company either partially or fully overturning the initial prior authorization denial in 2022.
