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February 12, 2020

Rothberg’s Hyperfine gets FDA OK to sell portable MRI

Hyperfine’s portable MRI can be rolled up to a patient’s bedside and produce a 3-D color image of a human brain within 10 minutes.
By Natalie Missakian

A Guilford startup founded by nationally known Connecticut serial entrepreneur Jonathan Rothberg will become the first company to sell a bedside MRI machine after getting the green light from federal regulators.

Hyperfine Research Inc. announced Wednesday morning that it has received 510(k) clearance from the U.S. Food & Drug Administration. The company said it will begin shipping the portable MRI this summer. 

Unlike traditional MRI machines that are confined to protected rooms, Hyperfine’s rolls up to the patient’s bedside, plugs into a standard AC wall outlet and is operated with an iPad. 

The device is a first in the medical-imaging industry, according to the trade publication Diagnostic Imaging. It is 20 times less expensive, 10 times lighter, and uses 35 times less power than a conventional MRI, according to Hyperfine. 

Rothberg has said the company would sell the device for around $50,000, a fraction of the more than $1 million price tag for traditional MRI machines. 

“Nearly six years ago, a dream to create a portable, affordable MRI system was born,” Rothberg said in a statement Wednesday. “We assembled a team, and they took the 10 million-fold improvement in computing power since MRI was invented, the best of the billions invested in green electronics and they built something astonishing, something disruptive.” 

Rothberg envisions the invention being used not only in hospital rooms, but on cruise ships, in ambulances and at sporting events. He also aims to bring MRI imaging to developing countries. Hyperfine Chief Medical Officer Kahn Siddiqui, MD, said 90 percent of the world has no access to MRI.

“More than 40 years after its first use, MRI remains a marvel. Unfortunately, it also remains inaccessible,” said Siddiqui in a statement. “It’s time that MRI made the jump to point-of-need, just like X-ray and ultrasound have before it.”  

“With the FDA’s decision, we are now ready to rewrite the rules of MRI accessibility,” he added. 

In testing the device, Hyperfine said thousands of brain scans were performed on patients at Yale New Haven Hospital, Penn Medicine, Good Samaritan Hospital on Long Island, New York Presbyterian Brooklyn Methodist Hospital and Brown University. The FDA clearance is for head imaging of patients age two and older.

Founded in 2014, Hyperfine is based in Rothberg’s 4Catalyzer health technology incubator, which has its flagship office in Guilford. Other locations include New York, Palo Alto, Calif. and Taiwan.

Rothberg, who lives in Guilford, won the National Medal of Technology & Innovation in 2015 for inventing inexpensive and accessible high-speed DNA sequencing. He also founded Guilford startup Butterfly Network, which developed a pocket-sized ultrasound device and has a valuation of more than $1 billion. 

Contact Natalie Missakian at news@newhavenbiz.com

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