Vapotherm Wins FDA’s 510(k) Clearance for Respiratory Therapy Device

Vapotherm has received 510(k) clearance from the FDA for its high-velocity respiratory therapy system HVT 2.0.

The HVT 2.0 can be used in the hospital or a home setting to provide therapy using an integrated air source and a paired oxygen source, the Exeter, N.H.-based company said.

Vapotherm plans to combine the HVT 2.0 with its Vapotherm Access digital remote patient monitoring platform “to begin learning how to treat complex lung disease patients in the home,” said the company’s CEO Joe Army.