Industry Articles
Updates about sleep-related diagnostic devices, therapies, products and companies
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. [...]
On Oct. 28, 2024, Neurovalens announced it launched its first product, Modius Sleep, an FDA-cleared, physician-prescribed medical device intended to treat chronic insomnia in adults. About Modius Sleep Modius Sleep is a portable, battery-operated neurostimulation device worn on the head for 30 minutes each [...]
On Oct. 17, 2024, Avadel Pharmaceuticals announced the FDA approved its supplemental new drug application for Lumryz for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. About Lumryz Lumryz is the only FDA-approved once-at-bedtime [...]