Qiagen has developed liquid biopsy panels for prostate and lung cancer and is set to introduce the products at the American Association for Cancer Research annual meeting this week.
Linking the experimental process to the design controls defined by FDA can help ensure an effective and efficient new product development effort, as well as a competitive market advantage.
FDA said 155 devices on the U.S. market are included in a recall of Penumbra's 3D Revascularization device because the delivery wire could break or separate during use. Amanda Pedersen Penumbra initiated a voluntary recall of its Penumbra 3D Revascularization device because of a risk...
Meridian Bioscience's diagnostics unit knew about its faulty blood lead test results for almost three years before FDA caught wind of the problem, the agency noted in its inspection report. Amanda Pedersen At best, Magellan Diagnostics ignored customer concerns about its faulty blood lead...
*/ FDA issued a safety warning regarding possible navigational accuracy errors linked to frameless stereotaxic navigation systems, although the agency said the overall benefits of using these systems continue to outweigh the risks. Amanda Pedersen Certain types of stereotaxic navigation...
FDA has not been able to identify the root cause of Magellan's inaccurate lead test results, and the recall has been expanded to include two additional testing systems. Amanda Pedersen FDA is conducting studies with the CDC to identify the cause of Magellan's faulty blood-based lead...
Zimmer Biomet recalled two implantable spinal fusion stimulators after a routine cytotoxicity test indicated high levels of chemicals that could be toxic to tissues or organs. Amanda Pedersen Zimmer Biomet is recalling its SpF PLUS-Mini and SpF XL llb implantable spinal fusion stimulators...
Are you aware of the regulatory changes and testing advances involving biocompatibility? Image of an in vitro irritation test courtesy Nelson Laboratories. Biocompatibility testing requirements for medical devices are changing. "A lot of things are happening, on all fronts," Thor Rollins...