neuro42, a medical technology Company leading the innovation of MRI and robotics for brain related diagnosis and treatment, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration for its portable diagnostic MRI scanner.
neuro42’s MRI System eliminates the need to transport a patient to an imaging suite, enabling timely diagnosis and improving treatment outcomes for patients with critical neurological conditions.
Related: Bone Solutions gets expanded FDA nod for Mg OSTEOCRETE in intervertebral procedures
“We are thrilled to announce the FDA clearance of our bedside MRI product,” said Abhita Batra, Founder and Chief Strategy Officer of neuro42. “Our team has been focused on making a difference in patient care, and now we can finally arm healthcare providers with a valuable tool to improve accessibility to neuroimaging.”
The Company aims to expand accessibility to MRIs and streamline the diagnostic process with actionable imaging in time sensitive environments, particularly for patients that are unable to undergo conventional MRI scans. This neuro42 MRI will be launched in the United States market later this year.
“This FDA clearance represents a significant milestone in neuro42’s growth, as we continue to drive innovation in medical imaging. We are committed to advancing the field of neuroimaging and addressing the evolving needs of providers and patients,” Abhita Batra added. The Company continues to innovate in the neurosurgical imaging arena with its robot integrated interventional MRI for surgical guidance.
