Makani Science Gains FDA Clearance for Innovative Respiratory Monitoring Device – U.S.

Makani Science, an innovator in wearable respiratory monitoring technology, announced that it has achieved 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market and distribute its Makani Respiratory Monitor.

This clearance validates patient safety, as well as the accuracy and reliability of Makani's innovative device, which is designed to continuously monitor respiratory rate in real time. The Makani Respiratory Monitor underwent comprehensive and rigorous testing and evaluation, successfully demonstrating its performance in a variety of clinical and real-world settings This 510(k) clearance is a significant milestone for the company, providing premarket approval for the Makani Respiratory Monitor.

This small comfortable unique monitor enables monitoring of ambulatory individuals rather than being hampered by wires. The monitor can provide continuous real-time information to iOS devices that can be accessed by patients and their healthcare providers. The immediate availability of respiratory performance provides an advantage over other respiratory monitors that provide delayed information. 

"FDA clearance opens the door to commercialization, clinical integration, and strategic partnerships," said Greg Buchert, MD, MPH, and CEO of Makani Science. "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."

With FDA clearance secured, Makani Science is moving forward with manufacturing, early clinical deployments, and research collaborations. The device is poised to support applications in hospitals, outpatient clinics, athletic performance monitoring, and early disease detection—anywhere continuous, non-invasive respiratory monitoring can make a meaningful difference.