Magna-Lab files 510(k) for niche MRI

Article

Niche MRI developer Magna-Labfiled for Food and Drug Administration 510(k) clearance last monthfor its Magna-SL extremity scanner. While the filing marks a milestonefor the Hicksville, NY, company, it will have to play catch-upwith competitor Lunar,

Niche MRI developer Magna-Labfiled for Food and Drug Administration 510(k) clearance last monthfor its Magna-SL extremity scanner. While the filing marks a milestonefor the Hicksville, NY, company, it will have to play catch-upwith competitor Lunar, which received 510(k) clearance last yearfor its Artoscan niche system (SCAN 11/3/93).

Magna-SL is a three-sided 0.3-tesla permanent magnet systemthat weighs about 5000 pounds. Magna-Lab intends to market thesystem as a scanner ideal for performing extremity scans at acost one-half to one-third of whole-body scanners. Magna-Lab mayalso promote the unit as capable of conducting brain scans.

While Magna-Lab waits for the FDA's go-ahead, it will moveforward with marketing efforts in Europe, where Magna-SL has regulatoryapproval. The company signed a $4 million sales and distributionagreement in January and will begin shipments in the second halfof this year. Initial sales could total $10 million if existingletters of intent and options are exercised. Magna-SL systemsare expected to sell for about $500,000.

Magna-Lab went public last year with an oversubscribed initialpublic offering that netted the firm $4.8 million (SCAN 5/5/93).

Recent Videos
Can AI Assessment of Longitudinal MRI Scans Improve Prediction for Pediatric Glioma Recurrence?
A Closer Look at MRI-Guided Adaptive Radiotherapy for Monitoring and Treating Glioblastomas
Incorporating CT Colonography into Radiology Practice
What New Research Reveals About Computed Tomography and Radiation-Induced Cancer Risk
What New Interventional Radiology Research Reveals About Treatment for Breast Cancer Liver Metastases
New Mammography Studies Assess Image-Based AI Risk Models and Breast Arterial Calcification Detection
Can Deep Learning Provide a CT-Less Alternative for Attenuation Compensation with SPECT MPI?
Employing AI in Detecting Subdural Hematomas on Head CTs: An Interview with Jeremy Heit, MD, PhD
Pertinent Insights into the Imaging of Patients with Marfan Syndrome
What New Brain MRI Research Reveals About Cannabis Use and Working Memory Tasks
Related Content
© 2025 MJH Life Sciences

All rights reserved.