People

Hyperfine Adds to its Top Management Team

Appointments aim to bolster Hyperfine's ability to drive Swoop system commercial adoption in hospital inpatient and outpatient settings.

The Swoop portable MR imaging system. Photo: Business Wire.

Hyperfine Inc. has appointed Chi Nguyen as vice president of Office Strategy and Partnerships, and Rafael Donnay as vice president of Hospital Strategy and Health Economics. The two hires aim to bolster Hyperfine’s ability to drive its Swoop system commercial adoption in hospital inpatient and outpatient settings, and expand to neurology office settings.

“The addition of Chi and Rafael to our leadership team is a pivotal step in our expansion and growth strategy,” Hyperfine President/CEO Maria Sainz said. “Their expertise in market development, commercialization of disruptive technologies, and health economics will be instrumental as we expand the Swoop system’s reach. With their leadership, Hyperfine is well-positioned to drive growth and transform care delivery in hospital and neurology office settings.”

Nguyen will lead the company’s office strategy, drawing on her extensive experience in developing markets for disruptive technologies. The new MRI standards issued by the Intersocietal Accreditation Commission (IAC) in November 2024 enable accredited neurology offices to secure CMS reimbursement for MRI scans using Hyperfine’s Swoop system. This milestone allows the company to expand into new sites of care, including neurology offices—representing nearly 2,400 potential U.S. locations. By bringing advanced MR brain imaging directly to these professional healthcare settings, Hyperfine will significantly enhance patient access and convenience by enabling MR brain imaging during routine clinic visits. To lay the foundation for this expansion, Nguyen will oversee an office pilot program in preparation for a full commercial rollout scheduled for mid-2025.

Nguyen is a seasoned medical device executive with more than two decades of experience in strategy, marketing, and market development, specializing in commercializing disruptive medical technologies. She previously served as vice president of Marketing at NeuroPace Inc., where she successfully led market expansion efforts from early launch through IPO. Her earlier roles include Spinal Modulation, Acclarent/Johnson & Johnson, Guidant Corporation, and Bain & Company. Nguyen earned an MBA from Stanford Graduate School of Business and a bachelor of arts degree from Yale University.

Donnay will lead the company’s hospital strategy, leveraging his expertise in commercialization, market development of new technologies, and health economics to position the Swoop system as an essential tool in a range of hospital settings. With a focus on market expansion, the company is targeting more than 9,600 potential sites of care in the United States, including 4,000 critical care units and 5,600 emergency departments. With a track record of successful commercialization of artificial intelligence-powered point-of-care EEG and extensive experience in the neurovascular space, Donnay will focus on integrating the Swoop system into hospital workflows to optimize patient care.

With more than 20 years of experience in medical technology, Donnay driven by a passion to improve healthcare using innovative and disruptive technologies. He most recently was senior vice president of Product and Reimbursement at CeriBell Inc., a leadership team member from Series A to IPO. Donnay’s prior marketing leadership roles include Philips, Stryker Neurovascular, and Medtronic. He earned an MBA from The Wharton School, an MS from Stanford University, and a bachelor of science degree from Columbia University.

Beyond the hospital and office business verticals, Hyperfine’s growth this year will be driven by international expansion efforts, supported by the CE approval of the latest AI-powered Swoop system software. This milestone positions Hyperfine for broader European commercial expansion of the Swoop system, bringing cutting-edge brain imaging technology to new global markets.

The Swoop Portable MR Imaging system is U.S. Food and Drug Administration (FDA)-cleared for brain imaging of patients of all ages. It is a portable, ultra-low-field magnetic resonance imaging device for producing images that display the internal structure of the head 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. The Swoop system also has CE certification in the European Union and UKCA certification in the United Kingdom. The Swoop system is commercially available in a select number of international markets.

Hyperfine Inc. is a health technology company that has redefined 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 Inc. scientists, engineers, and physicists developed the Swoop system to redefine brain imaging methodology and the ways in which clinicians can apply accessible diagnostic imaging to patient care.

Keep Up With Our Content. Subscribe To Medical Product Outsourcing Newsletters