FDA grants Breakthrough Device Designation to Vapotherm’s OAM

	The medical technology company has received Breakthrough Device Designation by the FDA for its Oxygen Assist Module (OAM).
	The OAM module is commonly used with most versions of Vapotherm’s Precision Flow systems. 


A global medical technology company focused on the development and commercialization of its patented Hi-VNI Technology products, Vapotherm Inc., has reportedly announced receiving the FDA Breakthrough Device Designation for its Oxygen Assist Module.

According to reliable sources, the FDA’s Breakthrough Device Program is envisioned to help patients and healthcare professionals receive timely access to novel technologies that carry the potential to offer effective treatment and diagnosis of life threatening diseases or conditions. In addition to this, the program also intends to create a pathway for prioritized FDA review of the OAM.

Moreover, the company has separately submitted an Investigational device Exemption for the pediatric use of OAM to the authorizing organization.

It has been reported that the OAM module is used with most versions of Vapotherm’s Precision Flow systems that incorporates the Hi-VNI Technology. For the record, Hi-VNI Technology is a mask-free and seal-free clinically approved substitute for nCPAP and NIPPV in adults and pediatrics. When simultaneously used with Precision Flow system, the OAM assists staff in maintaining a desired amount of oxygen level in the blood, or the SpO2 range.

Speaking on the matter, the President and CEO of Vapotherm, Joe Army stated that the company is elated to have received OAM Breakthrough device Designation from the FDA. Vapotherm is also looking into the possibilities of working closely with FDA officials to offer clinicians a solution which is highly effective for their patients.

The accurateness and efficiency of Vapotherm OAM algorithm was analyzed and evaluated in a 2018 study put forth by Reynolds and colleagues in the Fetal and Neonatal Edition of ‘Archives of Disease in Childhood.’ The data rolled out suggested that use of OAM device enabled the medical staff to maintain the targeted oxygen saturation range amongst premature infants to over 80% of the time, while providing considerably fewer manual adjustments to the oxygen delivered by the equipment.

Source credit: http://investors.vapotherm.com/news/news-details/2020/FDA-Grants-Vapotherm-Oxygen-Assist-Module-OAM-Breakthrough-Device-Designation/default.aspx