The FDA handed down a clearance in early June for Hyperfine's new scanner just days after giving the thumbs-up to its Optive AI image acquisition programs. (Hyperfine)

Portable MRI manufacturer Hyperfine has begun rolling out the next generation of its artificial-intelligence-equipped scanner-on-wheels following an FDA green light last month.

The former Fierce Medtech Fierce 15 winner’s Swoop system is designed for ultralow-field scans of the head and brain, with a mobile footprint that allows the scanner to be moved to the patient instead of the other way around—such as for delicate cases receiving intensive care or in pediatrics and smaller neurology clinics.

Hyperfine said two unnamed U.S. hospitals in the Northeast have put in the first commercial orders for the redesigned Swoop, with plans to deploy them in their ICUs and emergency departments.

“This marks the start of a new phase for Hyperfine—one where our vision to transform MRI access is driven by a new system that is commercially ready, is clinically valuable, has outstanding image quality and functionality, and is garnering strong customer interest,” Hyperfine President and CEO Maria Sainz said in a statement.

 “Attaining the milestone of first commercial sales and deliveries of the new Swoop system just weeks after FDA clearance is the result of seamless execution across the organization—from industry-leading product development to accelerated clearance to rapid manufacturing ramp to initial sales,” Sainz added.

The agency handed down a clearance in early June for the new scanner just days after giving the thumbs-up to its Optive AI image acquisition programs. Hyperfine described Optive AI as the tenth generation of its software—since the Swoop’s initial debut in February 2020—offering noise cancellation and other post-processing features.

Hyperfine has collected multiple regulatory green lights over the years adding upgrades to the system and AI programs.

Last month, the company also announced the appointments of Rob Fasciano, Ph.D., as chief regulatory and quality officer and Rafael O’Halloran, Ph.D., as VP of technology, saying their work has been instrumental in the development of Optive AI and the next-generation Swoop.

Fasciano joined the company after holding senior roles at Abiomed, Johnson & Johnson and Orchestra BioMed and most recently was Impulse Dynamics’ VP of regulatory affairs. O’Halloran previously led the AI-driven imaging development pipeline at Hyperfine and has served as an assistant professor of radiology at the Mount Sinai School of Medicine.