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Business Wire1y
LivaNova Unveils Essenz In-Line Blood Monitor with U.S. FDA 510(k) Clearance and CE Mark - Business Wire
LivaNova PLC today announced it received U.S. FDA 510(k) clearance and CE Mark for its Essenz™ In-Line Blood ... quarter and full-year 2024 results and issued full-year 2025 guidance ...
STAT1y
FDA proposes changes to key medical devices approval pathway
Last week, the FDA released a trio of guidelines clarifying the way it plans to evaluate devices that go through the 510(k) pathway. The agency is asking manufacturers to avoid predicate devices ...
The Victoria Advocate9mon
Piccolo Medical, Inc. Receives FDA Clearance for ECGuide™ Catheter Guidance Technology
SAN FRANCISCO, Sept. 16, 2024 /PRNewswire/ -- Piccolo Medical, Inc. (Piccolo) today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its innovative ...
Business Insider2y
Deep Blue Medical Advances Announces FDA Clearance for Sublay Application in Hernia Surgery, Enabling Broader Use of T-Line Hernia Mesh - Markets Insider
DURHAM, N.C., Dec. 5, 2022 /PRNewswire/ -- Deep Blue Medical Advances announced today it has received an additional 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its T-Line ...
Healthcare Dive1y
FDA proposes 3 guidances to improve 510(k) clearance process
As part of MDUFA V, the FDA committed to cutting the total time to decision for 510(k) submissions from 128 calendar days in 2023 to 112 calendar days in 2027. The goal is to issue a decision on ...