May 2026 Bunnell Incorporated received an FDA PMA supplement approval for the LifePulse® High Frequency Ventilator (HFV). The approval supported updates to the device platform, reinforcing continued regulatory maintenance and technology advancement for neonatal and pediatric respiratory care applications.
July 2025 ZOLL Medical Corporation received FDA approval for a PMA supplement related to the 3100 High Frequency Oscillatory Ventilator (HFOV) system. The approval supported modifications to the ventilator platform, including device updates for high-frequency respiratory support applications.
May 2025 The U.S. FDA recognized ISO 80601-2-90:2021, a safety and performance standard specifically covering respiratory high-flow therapy equipment. The recognition supported regulatory alignment for manufacturers developing high-flow respiratory therapy devices, including systems used for delivering heated and humidified high-flow oxygen therapy.
May 2025 GE HealthCare continued expanding the capabilities of its CARESCAPE R860 ventilator platform by supporting high-flow oxygen therapy functionality. FDA documentation confirmed the ventilator’s high-flow oxygen therapy mode, designed to deliver heated and humidified oxygen at controlled flow rates for spontaneously breathing patients requiring respiratory support.