FDA Clears First Patient-Specific Implant System For Total Knee Replacement
ConforMIS has received 510(k) clearance from the U.S. Food and Drug Administration to commercially market its iTotal CR Knee Replacement System. The iTotal CR is the only true patient-specific system available for patients who would traditionally receive a standard total knee replacement (TKR). The iTotal CR builds on ConforMIS' patented iFit technology for generating patient-specific implants ...

FDA Clears First Diagnostic Radiology Application For Mobile Devices
A new mobile radiology application cleared by the U.S. Food and Drug Administration will allow physicians to view medical images on the iPhone and iPad manufactured by Apple Inc. The application is the first cleared by the FDA for viewing images and making medical diagnoses based on computed tomography (CT), magnetic resonance imaging (MRI), and nuclear medicine technology, such as positron ...

Trade group cautiously upbeat on FDA plan
The FDA's plan for reforming the 510(k) program looks good on paper, but it's impact on the cost and time required for regulatory approvals is still unclear, said AdvaMed.