Summary: Resvent CPAP devices, including the iBreeze 20A (APAP) and iBreeze 30STA (BiPAP), are available in the United States under a US Food and Drug Administration (FDA) Emergency Use Authorization granted in April 2020. These devices are designed to improve patient adherence to therapy with features like automatic pressure adjustment, comprehensive humidity solutions, low noise, and remote management capabilities.
Key Takeaways:
- FDA Authorization: Resvent CPAP devices are available in the US under an FDA Emergency Use Authorization, which was granted in April 2020.
- Advanced Features: The iBreeze 20A (APAP) and iBreeze 30STA (BiPAP) offer features such as automatic pressure adjustment, comprehensive humidity management, and low noise levels to enhance patient comfort and adherence to therapy.
- Device Variants: The iBreeze 20A (APAP) is designed for automatic pressure adjustment to improve sleep quality, while the iBreeze 30STA (BiPAP) offers multiple modes and simplified operations for more tailored ventilation support.
Resvent CPAP devices are available in the United States under a US Food and Drug Administration (FDA) Emergency Use Authorization, which the company was granted in April 2020.
Units available in the United States include the iBreeze 20A (APAP) and the iBreeze 30STA (BiPAP). The iBreeze series features a range of capabilities designed to help improve patient adherence to therapy. The Resvent iBreeze 20A automatically adjusts the pressure to help users get a better sleep, while the Resvent iBreeze 30STA with muti modes meets different needs and simplifies operations to make ventilation easier on start.
Features of Resvent’s APAP and BIPAP with 4G/WiFi capabilities include:
- iBreeze 20A (APAP)
- Automatic leakage compensation
- Comprehensive humidity solution with automatic detection of ambient temperature and humidity and anti-dry heating function
- Low noise
- Remote management
- iBreeze 30STA (BiPAP)
- Low noise
- Algorithm ensures synchronization
- Comfortable humidification with eight levels of humidity
- Leakage compensation
FDA Emergency Use Authorization
On March 24, 2020, the FDA issued an umbrella Emergency Use Authorization in response to concerns about the insufficient supply and availability of FDA-cleared ventilators for use in health care settings to treat patients during the COVID-19 public health emergency.
This Emergency Use Authorization allows the emergency use of certain ventilators, anesthesia gas machines modified for use as ventilators, positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors, and ventilator accessories that the FDA determines meet specified criteria for safety, performance, and labeling.
Photo caption: iBreeze 20A (APAP)
Photo credit: Resvent
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