Tag: obstructive sleep apnea (osa)

LivaNova Receives U.S. FDA Premarket Approval for aura6000 System to treat Moderate to Severe Obstructive Sleep Apnea
Industry News Product News Sleep Apnea

LivaNova Receives U.S. FDA Premarket Approval for aura6000 System to Treat Moderate to Severe OSA

LivaNova PLC announced the U.S. Food and Drug Administration (FDA) granted premarket approval (PMA) for the aura6000™ System for the treatment of adult patients with moderate to severe Obstructive Sleep Apnea (OSA). The System utilizes proximal hypoglossal nerve stimulation (p-HGNS), a differentiated neurostimulation modality, to treat OSA in patients with […]

Sunrise Announces Landmark SUNSAS Trial Results, an At-Home Sleep Apnea Diagnostic Pathway Compared with PSG
Industry News Pharmacological

Sunrise Announces Landmark SUNSAS Trial Results, an At-Home Sleep Apnea Diagnostic Pathway Compared with PSG

Sunrise Group announced results from the SUNSAS clinical study, now published in The Lancet Regional Health – Europe, a leading international medical journal. Supported by the French Ministry of Health through the Forfait Innovation program, this study is the largest randomized controlled trial to date evaluating an at-home diagnostic pathway for obstructive […]

remsleep holdings deltawave
Industry News Product News Sleep Apnea

Full Commercial Launch of DeltaWave PAP Masks

REMSleep Holdings, Inc., developer of the FDA-cleared DeltaWave(TM) nasal pillow system, announced the full commercial launch of the DeltaWave product portfolio across all U.S. distribution channels, including durable medical equipment (DME) companies and institutional sales. With expanded FDA 510(k) clearance secured on January 15 and Medicare PDAC coding approved for every product […]

Clear Chronic Care Expands National Footprint as Medicare Infrastructure Partner for RPM, CCM and Quality Performance; Enters Sleep Medicine Market
Industry News Professional Practice

Clear Chronic Care Expands Nationally, Enters Sleep Medicine Market

Clear Chronic Care announced continued national expansion of its Medicare-focused Remote Patient Monitoring (RPM) and Chronic Care Management (CCM) platform, reinforcing its position as a long-term infrastructure partner to physician practices navigating value-based reimbursement. The company also announced strategic expansion into sleep medicine, where chronic oversight and adherence management are […]

ProSomnus Secures $38 Million Investment from Catalio Capital to Scale Smart Sleep Medicine
Dental Sleep Medicine Industry News Technology

ProSomnus Secures $38 Million Investment from Catalio Capital to Scale Smart Sleep Medicine

ProSomnus Sleep Technologies announced a strategic investment from Catalio Capital Management, L.P. to accelerate the global expansion of its technology-enabled sleep health platform. Under the agreement, Catalio, a premier healthcare-focused investment firm, has committed up to $38 million to advance development of next-generation remote patient monitoring (RPM) and proprietary sleep […]

Sunrise Announces Landmark SUNSAS Trial Results, an At-Home Sleep Apnea Diagnostic Pathway Compared with PSG
Artificial Intelligence Research & Studies Sleep Apnea Technology

Sunrise’s AI-Powered Measure of Respiratory Effort, REMOV, Better Reflects OSA Symptoms Than Traditional PSG Metrics

Sunrise Group, a pioneer in medical device innovation and sleep care announced a new peer-reviewed study in Nature Communications Medicine. Sunrise developed the only home sleep test with respiratory effort measurement that has been validated against esophageal pressure, the reference standard. The study reveals that REMOV, the Sunrise-specific marker of […]

Aurora CPAP Masks
Industry News Product News Sleep Apnea

Inogen Launches Aurora CPAP Masks

Inogen, Inc. has announced the launch of Aurora CPAP masks, a new product in its expanding portfolio. Aurora’s introduction marks a significant milestone in Inogen’s strategy to expand its respiratory care portfolio and now bring quality, high-performing masks to patients indicated for obstructive sleep apnea (OSA). Strategic Positioning and Market […]