FDA gives additional OK to point-of-care MRI

Hyperfine Research Inc. will begin rolling out a commercial launch for its Swoop Portable MR imaging device after receiving an additional 510(k) approval from the FDA, which will permit the system to be used on newborns and infants.

In a release, the Guilford, Conn.-based company defines Swoop as a “point-of-care MR imaging device that wheels directly to the patient’s bedside, plugs into a standard electrical wall outlet and is controlled through a wireless tablet.”

With the portable system in place, Hyperfine expects to make MR images more broadly available to patients, reducing wait times.

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

Read more
  • 0