Technologies has filed its 510(k) submission to the FDA for trigeminal nerve ablation earlier than previous guidance.

Medtronic (NYSE:MDT) announced today that it submitted 510(k) applications to the FDA seeking clearance for an interoperable ...

On March 17, 2025, Monogram (NASDAQ:MGRM) announced that the FDA has granted 510(k) clearance for its Monogram mBôs TKA System. This determination means that the company can move forward with ...

Medtronic has submitted 510(k) applications to the U.S. Food and Drug Administration seeking clearance for an interoperable pump.

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Companies must conduct robust risk-based assessments to determine whether modifications require a new 510(k) submission or other regulatory authorization. FDA’s guidance document, “Deciding ...

“Building on the success of our three product families that have already achieved 510(k) FDA clearance, we have accelerated our submission timeline for the OneRF Trigeminal Nerve Ablation ...

Medtronic (MDT) has submitted 510(k) applications to the FDA seeking clearance for an interoperable pump. FDA clearance of this pump would pave ...

(RTTNews) - Daxor Corporation (DXR), Thursday announced the submission of its next-generation blood volume analyzer - Daxor BVA - to the Food and Drug Administration (FDA). The company says that ...

EYSINS, Switzerland, April 3, 2025 /PRNewswire/ --Today, AliveDx announces it has submitted 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the MosaiQ AiPlex ...