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
Improving Access to Nuclear Imaging: An Interview with SNMMI President Jean-Luc C. Urbain, MD, PhD
SNMMI: 18F-Piflufolastat PSMA PET/CT Offers High PPV for Local PCa Recurrence Regardless of PSA Level
SNMMI: NIH Researcher Discusses Potential of 18F-Fluciclovine for Multiple Myeloma Detection
SNMMI: What Tau PET Findings May Reveal About Modifiable Factors for Alzheimer’s Disease
Emerging Insights on the Use of FES PET for Women with Lobular Breast Cancer
Can Generative AI Reinvent Radiology Reporting?: An Interview with Samir Abboud, MD
Mammography Study Reveals Over Sixfold Higher Risk of Advanced Cancer Presentation with Symptom-Detected Cancers
Combining Advances in Computed Tomography Angiography with AI to Enhance Preventive Care
Study: MRI-Based AI Enhances Detection of Seminal Vesicle Invasion in Prostate Cancer
What New Research Reveals About the Impact of AI and DBT Screening: An Interview with Manisha Bahl, MD
Related Content
© 2025 MJH Life Sciences

All rights reserved.