Business Wire

Nihon Kohden NKV-330 Ventilator System Receives US FDA 510(k) Clearance

IRVINE, Calif.--(BUSINESS WIRE)--Nihon Kohden OrangeMed, Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance for its NKV-330 Ventilator System. The NKV-330 is a non-invasive ...
Business Wire

ALung Receives IDE Approval to Conduct VENT-AVOID Trial of the Hemolung RAS for the US Market

PITTSBURGH--(BUSINESS WIRE)--ALung Technologies, Inc., today announced U.S. Food and Drug Administration (FDA) approval of its Investigational Device Exemption (IDE) to conduct a pivotal clinical ...
The American Journal of Managed Care

Dr Jeffrey Sippel Discusses CMS Ventilator Denials Impacting Patients With ALS

Industry stakeholders and patient advocacy groups are raising concerns with CMS due to high denial rates for non-invasive ventilators (NIVs) by Medicare Advantage plans. Industry stakeholders and ...
Medical Xpress

CPAP reduces need for invasive ventilation in hospitalized COVID-19 patients

The Respiratory Strategies in COVID-19; CPAP, High-flow, and Standard Care (RECOVERY-RS) trial has demonstrated that treating hospitalized COVID-19 patients who have acute respiratory failure with ...