The FDA clearance comes as Breathe prepares for market launch. The company will transfer its operations this year to a new facility in Southern California, where a number of major respiratory and sleep apnea device manufacturers are based.
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Breathe Technologies said that it has received FDA approval for the Breathe Technologies BT-V2S, a one-pound portable ventilator that can be used in the home. The ventilator can be used to treat respiratory conditions, including chronic obstructive pulmonary disease (COPD).
The FDA clearance comes as Breathe prepares for market launch. The company will transfer its operations this year to a new facility in Southern California, where a number of major respiratory and sleep apnea device manufacturers are based.