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The FDA is changing the way it categorizes investigational devices in an effort to help the Centers for Medicare & Medicaid Services make coverage determinations. Read More
The FDA approved its first blood-based genetic test to detect epidermal growth factor receptor gene mutations in non-small cell lung cancer patients. Read More
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