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A U.S. district court awarded CardiAQ $70 million in its suit against former service providers Neovasc, for allegedly stealing the company’s technology. Read More
Devicemakers and FDA are inching towards an agreement over MDUFA IV goals, but industry says additional resources and infrastructure are needed to achieve those goals. Read More
A Senate appropriations committee is requesting the FDA to provide documentation on de novo device approvals, classifications and postmarket surveillance standards. Read More
B. Braun Medical has agreed to resolve criminal liability allegations by paying $4.8 million in penalties and forfeiting an additional $4 million in restitution for selling contaminated pre-filled saline flush syringes in 2007, the Department of Justice announced. Read More
The FDA issued a warning letter to Eclipse Aesthetics because it had concerns that the firm’s MicroPen Elite dermabrasion device has the potential to damage vessels and nerves. Read More
The European Commission has published an updated version of harmonized standards that devicemakers and diagnostics makers can reference to ensure their products comply with relevant EU legislation. Read More