FDA Gives 510(K) Nod To Vapotherm's Next-Gen High-Velocity Therapy

  • The FDA has granted 510(k) clearance to Vapotherm Inc's VAPO HVT (high-velocity therapy) 2.0.
  • Vapotherm high-velocity therapy is mask-free noninvasive ventilatory support and is a front-line tool for relieving respiratory distress.
  • The 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. 
  • When paired with an oxygen source, the HVT 2.0 will support patients whether they need respiratory support in the hospital or home setting.
  • The company is planning a limited commercial release of HVT 2.0 in the U.S. in Q4 of 2021.
  • Related content: Benzinga's Full FDA Calendar.
  • Price Action: VAPO stock is up 4.27% at $28.57 on the last check Monday.
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