Industry Articles
Updates about sleep-related diagnostic devices, therapies, products and companies
On June 5, 2025, Avadel Pharmaceuticals announced that the FDA granted orphan drug designation to Lumryz, its extended-release sodium oxybate medication, for the treatment of idiopathic hypersomnia (IH). The FDA’s orphan drug designation provides incentives for drugs and biologics for the treatment of rare [...]
On May 19, 2025, Apnimed announced positive topline results from its Phase 3 SynAIRgy clinical trial of AD109 (aroxybutynin 2.5 mg/atomoxetine 75 mg), an investigational once-daily oral pill for adults with mild, moderate and severe obstructive sleep apnea across all weight classes. About [...]
On April 4, the FDA granted De Novo clearance to the Prapela SVS hospital bassinet pad, a vibrating mattress pad designed to stimulate rhythmic breathing in premature newborns with neonatal opioid withdrawal syndrome (NOWS) through gentle, randomized movements. About Prapela SVS [...]
On March 20, Sibel Health announced its ANNE View and Central Hub received FDA 510(k) clearance to display data from ANNE devices and third-party monitors, providing alerts, patient positioning insights and multi-patient monitoring to support health care professionals. About ANNE View, [...]
Compumedics announced March 5 that its Falcon HST device received FDA 510(k) clearance, expanding the company’s home sleep testing lineup in the U.S. About Falcon HST Falcon HST is an electroencephalogram (EEG) and respiratory signal recorder. It records, reviews and analyzes [...]
On Feb. 18, 2025, PranaQ announced it received FDA 510(k) clearance for TipTraQ, a compact home sleep apnea test (HSAT) wearable that uses advanced biosensors and AI algorithms to detect sleep apnea events and analyze sleep architecture with clinical-grade accuracy. About [...]
On Feb. 5, 2025, Huxley Medical announced that the FDA has cleared the SANSA home sleep apnea test to use cellular data upload, eliminating the need for Bluetooth pairing or apps, reducing failed home testing and simplifying the diagnostic process. About [...]
On Dec. 20, Eli Lilly announced the FDA has approved Zepbound (tirzepatide) as the first and only prescription medication for adults with moderate-to-severe obstructive sleep apnea and obesity. Read the FDA press release announcing Zepbound's approval for sleep apnea. The American Academy of Sleep [...]
On Dec. 3, 2024, Beacon Biosignals announced FDA authorization of a predetermined change control plan (PCCP) for the Dreem 3S, a wearable EEG headband designed for sleep monitoring, allowing for continuous sleep staging algorithm enhancements. About the Dreem 3S The Dreem 3S uses integrated machine [...]
On Dec. 2, 2024, Movano Health announced FDA 510(k) clearance for the pulse oximeter in its EvieMED Ring. About the EvieMED Ring The EvieMED Ring is a finger wearable device featuring a small gap in the ring surface and slight flex to accommodate finger swelling. [...]