Hyperfine receives FDA 510(k) clearance for portable MRI system

14 August 2020 (Last Updated August 14th, 2020 14:09)

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

Hyperfine receives FDA 510(k) clearance for portable MRI system
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.

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.”

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.