Two new members have joined Hyperfine Inc.’s C-Suite. The company recently appointed Rob Fasciano, Ph.D., as chief Regulatory and Quality officer, and Rafael O’Halloran, Ph.D., as vice president of Technology.

These new leadership additions were instrumental in developing the U.S. Food and Drug Administration (FDA)-cleared Optive AI software and the new, next-generation Swoop system scanner. Their work will help with the global rollout of this new technology and the development of future software enhancements.

“These appointments further strengthen our capabilities as we scale the commercialization of our next-generation Swoop system with Optive AI software,” Hyperfine President/CEO Maria Sainz said. “Technology innovation is at the core of our mission and central to accelerating global adoption of the Swoop system. Raf has been instrumental in elevating our imaging performance to the standard we deliver today. Rob joins at a pivotal time as we translate that innovation into globally cleared, commercially scalable products. I’m thrilled to have such talented and experienced leaders on the Hyperfine team as we continue to advance our mission and extend our reach to transform brain health.”

Dr. Fasciano has more than 25 years of leadership experience in regulatory affairs, quality systems, and R&D in the medical device and diagnostics space. He has held senior roles at Abiomed, Johnson & Johnson, Orchestra BioMed, and Impulse Dynamics. Dr. Fasciano earned a Ph.D. from Johns Hopkins University, an MBA from Purdue University, a master of science degree from Boston University, and a bachelor of arts degree from Dartmouth College.

Dr. O’Halloran has more than two decades of experience in MRI physics focused on innovation in sequence development and image reconstruction. Most recently, he led the development of the AI-driven image pipeline at Hyperfine. Previously, he was an assistant professor of Radiology at the Mount Sinai School of Medicine, focusing on the use of diffusion-weighted imaging in neuromodulation and the study of psychiatric disorders. Prior to his Mount Sinai work, he was a research associate at Stanford University. Dr. O’Halloran earned a Ph.D. in medical physics from the University of Wisconsin-Madison and a bachelor of science degree in physics from Louisiana State University.

Hyperfine’s Swoop Portable MR Imaging Systems are FDA-cleared for brain imaging. They are portable, ultra-low-field magnetic resonance imaging devices for producing images that display the head’s internal structure where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

Hyperfine Inc. is redefining brain imaging with the Swoop system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of professional care. Founded by Dr. Jonathan Rothberg in a technology-based incubator called 4Catalyzer, Hyperfine scientists, engineers, and physicists developed the Swoop system out of a passion for redefining brain imaging methodology and the ways in which clinicians can apply accessible diagnostic imaging to patient care.