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 are delivering on our mission to democratize healthcare across clinical settings and geographies.”
The company says Swoop – which is designed as a complementary system to traditional MRIs – captures the images right at the patient bedside, giving physicians the ability to act quickly. According to the company, The complete Hyperfine system costs less than the annual service contract alone for most current MRI systems, and it consumes 35 times less power than those same systems.
Training takes only 30 minutes, the company said.
