A Guilford company has picked up another FDA clearance for its portable MRI machine, this time allowing the device to be used to image the brains of newborns.
Hyperfine Research Inc., founded by Connecticut bioscience entrepreneur Jonathan Rothberg, said the new FDA clearance covers enhanced imaging and software, while expanding brain imaging to include patients up to age 2.
With the latest clearance, the company has officially begun marketing the machine commercially, saying shipments will begin immediately. Hyperfine also unveiled a name for the device: Swoop.
“Our system was designed from Day 1 to be mobile, to bring [MRI] to the patient,” Chief Medical Officer Khan Siddiqui, MD, told New Haven Biz in an email. “We ‘swoop’ in to nimbly provide MR imaging at the patient’s bedside.”
He said the name also reflects the emphasis the company places on simplicity and ease of use.
Hyperfine’s Swoop rolls up to the patient’s bedside, plugs into a standard AC wall outlet and is operated with an iPad. It received its first FDA clearance in February for brain imaging of patients age 2 and up.
Fixed MRI systems are often shielded in protected rooms, making them inconvenient and inaccessible to some patients, particularly those too unstable to be moved, Hyperfine said. The Swoop, in contrast, can be used right in the emergency room or intensive care unit.
“This next generation device really expands our capabilities to provide bedside imaging to patients of all ages, including infants, so that health care providers can make important diagnostic decisions quickly,” Siddiqui said. “It’s also reassuring that families can stay with the patient as the process takes place.”
Rothberg unveiled the machine last October at the American College of Emergency Physicians’ annual conference in Denver. The latest version includes technological enhancements and incorporates user feedback, Hyperfine said.
Rothberg has said previously he planned to sell the device for around $50,000, while conventional MRI machines can cost upwards of $1 million.
Because it is more affordable and requires less power and maintenance, it can help bring MRI to developing countries and rural areas, Rothberg has said.
Contact Natalie Missakian at news@newhavenbiz.com
