This article was originally published in The Gray Sheet
Executive SummaryFDA clears Long Island, New York firm's 510(k) for its Magna- SL "open design" magnetic resonance imaging scanner for extremities. The open system allows physicians "to produce, for the first time, weight-bearing and fully bent-limb scans and eliminates the claustrophobic reactions which cause some patients to refuse scans" in standard full-body MRI scanners, according to Magna-Lab. The system, priced at $500,000, will be sold by Magna- Lab's direct sales force to small hospitals, emergency rooms, and private physicians. The Magna-SL is currently being sold in Europe and the Middle East through a network of distributors
You may also be interested in...
Japanese firm in discussions with regulator as high-need novel therapy for spinocerebellar degeneration misses endpoint but shows promise in pooled analysis.
The FDA has readied plans for hastened emergency-use approvals of coronavirus test kits after an infected US citizen returned to Washington State from Wuhan province in China. See what the FDA’s Megan McSeveney said about it here.
Despite obvious similarities in the contentious reviews of Sarepta’s Vyondys 53 and its predecessor Exondys 51, drug developers should focus on the differences between the two reviews.