GUILFORD, Conn. – Hyperfine, Inc. (Nasdaq: HYPR), the company behind the world’s first FDA-cleared, AI-powered portable MRI system for brain imaging, has announced two key leadership appointments aimed at accelerating global expansion and further advancing its next-generation imaging technology.
Rob Fasciano, PhD, has joined Hyperfine as Chief Regulatory and Quality Officer, and Rafael O’Halloran, PhD, has been appointed Vice President of Technology. Both played critical roles in the development of the company’s recently FDA-cleared Optive AI™ software and the launch of the enhanced Swoop® system, a portable MRI scanner designed for use at the point of care.
Dr. Fasciano brings more than 25 years of experience in regulatory affairs, quality systems, and medical device R&D. He has held senior leadership positions at major medical technology companies including Abiomed, Johnson & Johnson, Orchestra BioMed, and Impulse Dynamics. He earned a PhD from Johns Hopkins University, an MBA from Purdue University, an MS from Boston University, and a BA from Dartmouth College.
Dr. O’Halloran, now leading technology efforts at Hyperfine, has more than two decades of experience in MRI physics, with a focus on image reconstruction and sequence development. Prior to his role at Hyperfine, he served as an assistant professor of radiology at the Mount Sinai School of Medicine, where he focused on diffusion-weighted imaging in neuromodulation and psychiatric research. He also conducted postdoctoral research at Stanford University and holds a PhD in medical physics from the University of Wisconsin-Madison.
“These appointments further strengthen our capabilities as we scale the commercialization of our next-generation Swoop® system with Optive AI™ software,” said Maria Sainz, President and CEO of Hyperfine. “Innovation in imaging technology is central to our mission. Raf has been instrumental in elevating our imaging performance, and Rob brings the expertise needed to ensure our products meet global regulatory and quality standards. Their leadership will be key as we continue expanding access to portable brain imaging around the world.”
The Swoop® system and Optive AI™ represent a major shift in how brain health can be monitored and diagnosed—offering clinicians an affordable, accessible solution for use in hospitals, ICUs, and underserved regions where traditional MRI infrastructure may be unavailable.
