Lungpacer Medical gains FDA premarket approval for AeroPace® System
Published: 6 December 2024
Following the news below from September announcing Lungpacer Medical’s submission, we’re delighted that the AeroPace® System has received premarket approval. It is the first device of this kind approved by the FDA.
For further information, see Lungpacer Medical’s press release.
Published: 25 September 2024
Medical device company, Lungpacer Medical, has announced its AeroPace® System is under Food and Drug Administration (FDA) review in a premarket approval (PMA) application.
Lungpacer specialises in developing minimally invasive technologies designed to reduce ventilator-induced injury and help patients wean off mechanical ventilation (MV) and breathe on their own. The AeroPace® System is designed to stimulate the nerves that activate and exercise the diaphragm to improve diaphragm strength and weaning from MV.
This technology gained prominence during the COVID-19 pandemic when ventilators played a critical role. Lungpacer received FDA Breakthrough Device designation and Emergency Use Authorisation (EUA) for patients on MV during the pandemic.
The AeroPace® System features an industrial design that considers user experience, interface, and ergonomics, making it well-suited for intensive care units (ICUs). It also complies with regulatory standards for medical electrical equipment and human factors engineering guidelines.
Lungpacer’s submission of the PMA application marks a significant milestone in the development and potential market introduction of this novel technology.
