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January 19, 2021

FDA clears AI software for Hyperfine’s 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

Federal regulators have given the green light to artificial intelligence software for a new portable MRI machine being marketed by a Guilford company.

The Food and Drug Administration granted 510(k) clearance to Hyperfine’s Advanced AI image software for the company’s portable MRI machine, Swoop.

Company officials say the AI software will help doctors analyze scans and diagnose brain diseases, such as strokes. The Advanced AI Applications analyze and return annotated and segmented brain images within minutes of scanning.

“With this powerful tool now built into the Swoop system, we are making MR imaging not only accessible at the bedside, but making it easier for providers to move quickly from scan to a recommended course of treatment,” said Hyperfine Chief Medical Officer Dr. Khan Siddiqui in a statement.

While traditional MRI machines must be 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. 

Hyperfine, founded by prominent Connecticut bioscience entrepreneur, genomics pioneer and New Haven native Jonathan Rothberg, began marketing the device this summer at a fraction of the cost of conventional machines. 

The FDA cleared the machine last year to take brain images in patients ranging from newborns to adults. 

Read a previous New Haven Biz story on Hyperfine’s portable MRI here. 

Contact Natalie Missakian at news@newhavenbiz.com

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