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The FDA has finalized a guidance on interactive reviews to include commitments it made in the MDUFA III commitment letter and to expand use of the process. Read More
“Accurate detection … is critically important in efforts to successfully detect and potentially reduce the incidence of cervical cancer,” Cepheid CEO John Bishop says. Read More
The FDA last month approved St. Jude Medical’s Allure Quadra Cardiac Resynchronization Therapy Pacemaker (CRT-P), Assurity pacemaker and Endurity pacemaker families of devices. Read More
Sponsors of 510(k)s for electrosurgical devices and bipolar electrosurgical vessel sealers intended for general surgery should test the biocompatibility of all materials that will come into contact with the patient, a pair of FDA guidances recommend. Read More
The FDA’s Molecular and Clinical Genomics Devices Panel voted yes, and yes again, to recommend approval of two new colon cancer diagnostics, paving the way for a new generation of less-invasive tests to screen for the disease. Read More