Hyperfine received FDA for its category-defining portable MRI technology, the Swoop Portable MR imaging system. Credit: Business Wire.

Hyperfine Research has received 510(k) clearance from the US Food and Drug Administration (FDA) for the Swoop Portable MR imaging device.

The Swoop system, which is designed to be a point-of-care MR imaging device, wheels directly to the patient’s bedside. It can be plugged into a standard electrical wall outlet and can be controlled using a wireless tablet.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The FDA clearance for the device includes enhanced imaging and software and extends Hyperfine’s brain imaging indication to include patients aged between zero and two.

The company’s latest-generation device Swoop incorporates user feedback and technological upgrades, evolving from the original device, which was cleared by the FDA in February.

Hyperfine Research founder and chairman Jonathan Rothberg said: “Six years ago, we had a crazy vision to create a new product category for imaging – an affordable point-of-care MRI system.

“With this clearance from the FDA, we are launching an astonishing new diagnostic tool for patients and providers in our Swoop Portable MRI and we are delivering on our mission to democratise healthcare across clinical settings and geographies.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

According to the company, the Swoop system addresses the drawbacks of the existing imaging technologies and makes MRI more accessible to patients at all times and anywhere.

It is designed as a complementary system to traditional MRIs and enables critical decision-making in a variety of clinical settings by performing scans at the patient’s bedside and delivering results in minutes.

The complete Hyperfine system costs less than the annual service contract alone for most existing MRI systems, noted the company.

Hyperfine is currently offering the device for commercial purchase and the shipments are expected to begin shortly.