NuvoAir’s Air Next Achieves 510(k) Clearance for At-Home Use

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Key Highlights

  • 510(k) clearance grants Air Next Spirometer in-home use for comprehensive spirometry.
  • Enables real-time lung health monitoring, reducing hospital visits for COPD, Asthma, and ALS patients.
  • Supports ATS 2019-compliant spirometry, expanding clinical trial capabilities across the US and Europe.

Source: Business Wire

Notable Quotes

  • “Air Next is capable of providing our care team with high-quality lung measurements from the comfort of our patients’ homes,” – Eric Harker, MD MPH MBA, Chief Medical Officer at NuvoAir
  • “Air Next brings the reliability of in-clinic spirometry right to our patients’ hands,” – Furat Shawki, General Manager of Clinical Trials at NuvoAir

SoH's Take

The 510(k) clearance of NuvoAir’s Air Next Spirometer marks a pivotal advancement in pulmonary healthcare. This breakthrough not only signifies a leap in patient-centric care but also heralds a new era of efficiency and precision in chronic lung condition management. By enabling at-home, high-quality lung monitoring, NuvoAir is setting a new standard in proactive care, ensuring that patients with critical respiratory conditions receive timely interventions, thus minimizing the need for hospital admissions. Moreover, the integration of ATS 2019-compliant spirometry into clinical trials signifies an innovative stride in respiratory research, broadening the horizon for future advancements in cardiopulmonary healthcare solutions. As NuvoAir continues to blend cutting-edge technology with patient-focused care, its role in transforming the landscape of respiratory health management becomes increasingly indispensable.

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