Hyperfine Research has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Swoop portable magnetic resonance imaging (MRI) system.
Swoop is a point-of-care (POC) MR imaging device, which can be directly placed at the patient’s bedside and connected to a standard electrical wall outlet. The system will be controlled through a wireless tablet such as an Apple iPad.
The clearance of the market-ready device is said to cover enhanced imaging and software, as well as expand Hyperfine’s brain imaging indication to include patients aged between zero and two.
Hyperfine’s latest-generation device integrates user feedback and technological enhancements evolving from the original device, which was approved in February this year.
Hyperfine’s latest-generation device will help address the limitations of current imaging technologies
The company has developed the Swoop system to address the limitations of current imaging technologies and provide MRI anytime and anywhere for any patient.
Hyperfine’s system allows to capture images at the patient’s bedside and offers results within minutes.
The system facilitates critical decision-making capabilities across different clinical settings, including neurointensive care units, emergency departments, paediatrics, ambulatory and outpatient surgery centres.
According to the company, the complete Hyperfine system absorbs 35 times less power than the traditional current MRI systems.
Swoop portable MRI system, which is a complementary system for traditional MRIs, enables new users to train on system operation, device navigation and device safety within 30 minutes.
Hyperfine Research founder and chairman Dr 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 democratize healthcare across clinical settings and geographies.”
Hyperfine is part of 4Catalyzer, a health technology incubator that manages facilities in Connecticut, New York City, Palo Alto, and Taiwan.
In October 2019, Hyperfine Research first unveiled the new POC MRI system, which is designed to be used anytime and anywhere for any patient who requires it.
