Bringing MRI to the patient, not the other way around.
Chairman and founder: Jonathan Rothberg
Based: New York City and Guilford, Connecticut
The scoop: For about $5,000 a month, you can get your hands on a genuine, bonafide, electrified MRI—courtesy of Hyperfine Research, which aims to disrupt the market as much as it plans to innovate imaging technology with its portable scanner-on-wheels.
The company pitches its Swoop system not only as a reimagining of a hospital’s typical, 20,000-pound-plus scanner but also as a wholly new diagnostic approach that is built to compete with the relatively more flexible and common X-ray and CT machine.
Hyperfine’s scanner is the world’s first MRI that is small and light enough to fit in an elevator, and it's designed to be rolled to a patient’s bedside for scans of the head and brain. It can be plugged into an everyday power outlet and is controlled by a dedicated iPad.
It could prove especially useful for patients who are in intensive care units or at high risk for strokes. By allowing the scanner to be brought to them, instead of undertaking a potentially risky transfer through the hospital to its basement radiology wing, a patient can be treated and still be surrounded by life-sustaining machines and their staff.
The company received its first FDA clearance in February 2020 and returned with a new green light for a second generation of the device only six months later— and 49 days after submitting it to the agency—allowing its use for people of all ages.
Since then, Hyperfine has also secured clearance for artificial intelligence software, which alerts for signs of traumatic injuries, including shifts in the midline separating the brain’s hemispheres as well as measurements of cavities filled with cerebrospinal fluid.
“I think of our device as a workflow solution,” Hyperfine’s chief medical and chief strategy officer, Khan Siddiqui, said in an interview. “At the end of the day, imaging is a way to make faster decisions on whomever you’re treating.”
This includes future plans for push-button protocols that scan for brain bleeds and strokes.
“If you’re just generating images, it’s not really helping with the decision-making process—it doesn't really do much,” Siddiqui said. “Our focus is really on how we can help that clinician, as well as the patient, derive those decisions faster and right at the point of care.”
What makes Hyperfine fierce: As the COVID-19 pandemic began to spread over the past year, Hyperfine worked to make sure that its employees could work remotely and that its manufacturers and suppliers were in alignment and could continue scaling up their production.
Then, as researchers made it clear that the coronavirus affects far more than the lungs—and can bring neurological complications such as strokes, encephalitis and cognitive impairment—the company launched a program to make scanners available free of charge for COVID wards and patients.
“That was one of the reasons that we launched so fast,” Siddiqui said. “For us to be able to deliver scanners in April, that time frame meant we had to really ramp up all of our manufacturing.”
For a commercial rollout in the middle of a pandemic, production is only half of the challenge. Getting it to work in the hands of clinicians is the other.
To make it happen, Hyperfine’s staff developed a series of virtual training sessions and roadshow demonstrations, including videos and webinars filmed out of a mock ICU set up in the company’s offices. In the end, they realized the whole process allowed them to deploy that much faster, with technicians learning how to use the device in about half-an-hour.
“Now we show up with the delivery at 10 a.m., and by 3 p.m. they’re scanning patients and we're gone,” he said.
The miniaturization of medical scanners is also being pursued by other companies large and small. Diagnostic imaging is expected to grow into a $51 billion worldwide business in the next four years.
For example, Synaptive’s newly cleared, 0.5 Tesla MRI machine is less mobile, but still light enough to be placed on any floor of a hospital without structural reinforcements. Meanwhile, imaging giant Siemens Healthineers has debuted a wheeled CT scanner that one person can move and operate themselves.
All of these devices aim to bring medical imaging to places where it simply wasn’t feasible before, and Hyperfine aims to become a full-solution provider.
“Our mission is really to democratize healthcare, so we don't bubble ourselves just as an MRI company,” Siddiqui said. “We want to make sure that we are thinking about all the things that surround our device as people are using our workflow.”
“If there are gaps we will fill those gaps—be it software, be it consumables, be it whatever it is that needs to be developed as part of our whole solution,” he said. “If something exists, we will partner with those entities. If it doesn't exist, we will own it and make it happen.”
“I mean, even now, everybody’s shocked that we have the price of an MRI scanner listed on our website—nobody in the industry does that, right?”
Investors: Hyperfine recently raised $90 million in a February series D round, with backers including GV, formerly known as Google Ventures, alongside Nextrans, Axiom Associates, Huami, Colle Capital, LSS and Altium Capital.