Makani Science has received 510(k) clearance from the US Food and Drug Administration (FDA) for its wearable respiratory monitoring system, allowing the company to market and distribute the device across the US healthcare sector.
The approval confirms the device meets regulatory standards for safety and performance.
Makani Science CEO Greg Buchert said: “FDA clearance opens the door to commercialisation, clinical integration, and strategic partnerships.
“It’s not just a regulatory win—it’s a strong endorsement of the technology we’ve worked tirelessly to develop and refine. As a physician, I am confident we will improve the health and lives of individuals who use the Makani Respiratory Monitor.”
The company’s respiratory monitor is designed to track breathing rate continuously in real time through a lightweight, wireless form factor.
Unlike conventional respiratory monitors that rely on wired connections and provide delayed data, the Makani Science device transmits information directly to iOS-compatible platforms, making it accessible to both patients and healthcare providers.
Makani Science stated that the device had undergone extensive clinical and technical testing prior to regulatory approval. These evaluations demonstrated its operational accuracy and reliability in both clinical environments and real-world conditions.
The company confirmed the product will now be used in hospital settings, outpatient clinics, and research institutions, as well as for athletic performance monitoring and early identification of respiratory conditions.
Following the FDA’s decision, the Irvine, California-based firm plans to begin scaled manufacturing and early-stage clinical implementation. It is also engaging in research partnerships to explore further use cases.
The Makani Respiratory Monitoring System has been developed to support continuous, non-invasive observation of respiratory function across medical and non-medical settings.
The company noted that the wireless design enables the monitoring of individuals while they are ambulatory, removing limitations associated with traditional wired systems. It added that the real-time respiratory data stream provides faster insights compared to monitors that rely on retrospective analysis.
Founded as a medical technology company focused on respiratory analytics, Makani Science is working to introduce its solution to healthcare providers and researchers seeking improved methods of tracking breathing metrics over extended periods without invasive or obstructive equipment.
