under a 510(k)-exempt classification. This milestone enables Neurocast to bring its breakthrough technology to the U.S. market, starting with multiple sclerosis (MS). With this FDA device listing ...

Neurocast.ai, a digital health company transforming brain health monitoring, has officially registered its passive monitoring platform with the U.S. Food and Drug Administration (FDA) under a ...

announced today that they received FDA 510(k) clearance to market the LINKT™ Compression Staple System. The staple system offers a range of nitinol staples for fracture repair, joint fusion ...

The US Food and Drug Administration (FDA) has awarded 510(k) clearance to Fujirebio’s Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio in vitro diagnostic (IVD) test for evaluating amyloid ...

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The FDA has granted 510(k) marketing clearance to the first in vitro blood-based biomarker diagnostic device for Alzheimer’s disease. Fujirebio’s Lumipulse G pTau217/ -Amyloid 1-42 Plasma ...

That test was the predicate device to which the new Fujirebio diagnostic was compared under the FDA’s 510(k) pathway. The FDA found that the new Lumipulse test was substantially equivalent to ...

The decrease in R&D was partially offset by a $250,000 performance-based compensation accrual during the quarter from the FDA 510(k) clearance grant for the mBôs™ TKA System. General ...

Sara Moniuszko is a health and lifestyle reporter at CBSNews.com. Previously, she wrote for USA Today, where she was selected to help launch the newspaper's wellness vertical. She now covers ...

Submission based on positive data from two pivotal studies, which both met their primary endpoints U.S. clearance expected in Q3 2025 based on average observed review timelines for radiological ...