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# Vapotherm Gets ‘Breakthrough’ Status for Oxygen Assist
- URL: https://www.fdaweb.com/vapotherm-gets-breakthrough-status-for-oxygen-assist/
- Published: 2020-04-09T12:00:00.000Z
- Updated: 2026-09-14T16:10:46.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146534

FDA has granted Vapotherm a breakthrough device designation for its Oxygen Assist Module for use in the company’s Precision Flow system, a mask-free alternative to nasal continuous positive airway pressure as well as noninvasive positive pressure ventilation. The module assists staff in maintaining a targeted SpO (amount of oxygen in the blood) range, the company says.

The effectiveness of the Vapotherm OAM algorithm was evaluated in a [2018 study published](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Ffn.bmj.com%2Fcontent%2F104%2F4%2FF366&esheet=52201183&newsitemid=20200409005334&lan=en-US&anchor=2018+study+published+by+Reynolds+and+colleagues&index=1&md5=eee329738a216062d9f2f40a2754b67d&mod=article%5Finline&ref=fdaweb.com) in the *Archives of Disease in Childhood*. “The data show that trained staff using manual controls alone were able to maintain premature infants’ oxygen saturation in the physician-prescribed target range 49% of the time,” the company says. “When using the OAM device, the staff were able to maintain the target oxygen saturation range 80% of the time, while at the same time requiring significantly fewer manual adjustments to the oxygen delivered by the equipment.”