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Company on track to commence U.S. clinical studies in 2025 to support a De Novo application for FDA approval THE WOODLANDS, ...

Shockwave Medical has commenced the IDE study of the Javelin Coronary IVL Catheter for treating calcified coronary lesions.

Johnson & Johnson MedTech‘s  Medical announced today that it initiated a study evaluating its Javelin coronary IVL catheter.

CTSO READ THE FULL CTSO RESEARCH REPORT Update on the DrugSorb-ATR Regulatory Process Management reiterated that their De Novo DrugSorb-ATR submission continued to be in interactive review with FDA, ...

Apple Inc. (NASDAQ: AAPL) is reportedly working on an AI-driven health coach, under the codename Project Mulberry, as a ...

March 28, 2025 /PRNewswire/ -- Today, Visby Medical™, a leading innovator in medical diagnostics, announced that the U.S. Food and Drug Administration (FDA) has granted De Novo authorization ...

March 28, 2025 /PRNewswire/ -- Today, Visby Medical™, a leading innovator in medical diagnostics, announced that the U.S. Food and Drug Administration (FDA) has granted De Novo authorization for ...

After 12 years of development, our device delivers rapid ... The granting of this De Novo marketing authorization positions Visby Medical for significant expansion into the at-home diagnostics ...