Brendan O’Leary

Mechanical Engineer Food and Drug Administration

Brendan O’Leary is a lead reviewer for premarket radiological device submissions at the FDA. As an expert on the 510(k) device clearance process, Brendan has led the review and clearance of approximately 75 devices over the last several years, including mobile apps for diagnostic radiology and radiation treatment quality assurance. Before joining FDA, Brendan designed tools that astronauts used to repair and upgrade the Hubble Space Telescope during spacewalks in 2009. He also helped develop, prototype, and test a computer vision, GPS, and inertial navigation and object identification system for the blind.