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Members of the medtech industry concerned that EU device regulations expected this summer will conflict with aspects of the new version of ISO 13485 can rest easy, one expert says. Read More
Inspections conducted by France’s ANSM of makers of implantable defibrillation leads found qualification and validation processes were the largest compliance problems. Read More
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