The Magazine for Sleep Professionals
Thursday, May 7, 2026
Vapotherm, Inc. announced it has received 510(k) clearance from the US Food and Drug Administration for HVT 2.0. This next-generation system is designed to provide high-velocity therapy using an integrated air source, eliminating the need for wall air or any pressurized air source. It is estimated that 50% of U.S. […]
Vapotherm, Inc., a global medical technology company focused on the development and commercialization of its proprietary Hi-VNI® Technology products that are used to treat patients suffering from respiratory distress, announced a major expansion in its capital equipment manufacturing capabilities. This expansion is expected to enable the company to increase production […]
Vapotherm, Inc. has announced that the FDA recently granted Breakthrough Device Designation for the Company’s Oxygen Assist Module (OAM). FDA’s Breakthrough Device Program is intended to help patients and healthcare providers receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis of […]
Vapotherm, Inc. announced that it has received the CE Mark for its Vapotherm Oxygen Assist Module (OAM). When used with a Precision Flow® system, the Vapotherm OAM helps clinicians keep their patients within the target oxygen saturation range more effectively than with manual control alone. Keeping babies in the prescribed oxygen […]
Study found that Hi-VNI Technology during ambulation is feasible Hi-VNI Technology improved recovery time amongst these patients by 32.5% versus standard oxygen therapy Hi-VNI Technology improved patient distance walked by 12.4% and duration of time walked by 8.5%. vs. standard oxygen therapy amongst the inpatient group of these patients Vapotherm, […]
Vapotherm is offering a free webinar Wednesday, August 28th, 2PM – 3PM on the latest clinical research on High-Velocity Nasal Insufflation (HVNI). Presenter Kirk Hinkley, MD will share his clinical experience using HVNI as a front line tool for treating the signs and symptoms of respiratory distress in the Emergency […]
Vapotherm, Inc. announced the release of the next generation of its capital unit: the Precision Flow Hi-VNI system. For this generation of the Precision Flow® system, both the hardware and software have been updated to improve reliability, and to comply with the EMC 4th Edition requirements for medical devices, IEC 60601-1-2:2014. As […]
Vapotherm, Inc. (Vapotherm) today announced that the U.S. Food and Drug Administration (FDA) has granted Vapotherm’s latest version of the Precision Flow® product, the Precision Flow Hi-VNI™ system, a new product category and product code (QAV). The FDA also granted an expanded indication for the system that states it may […]
