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The system, which has an over-the-wire design, is able to protect the patient’s lower limbs during angioplasty and requires no additional devices or exchanges. Read More
The FDA issued separate draft guidances on blood glucose monitors used in health care settings and on over-the-counter products used in the home. When finalized, they will replace guidances the agency issued in 2016. Read More
The FDA has withdrawn a proposed rule that would have required manufacturers to submit labels and package inserts in electronic format for certain home-use medical devices. Read More
Monteris is releasing a new version of its NeuroBlate probe to address a problem with overheating of its magnetic resonance-guided laser thermal therapy device. The new probe is equipped with a non-metallic fiber optic sensor. Read More
The FDA plans to continue building out its National Evaluation System for health Technology (NEST) and it is increasing its focus on device therapies unique to women, Commissioner Scott Gottlieb and CDRH Director Jeff Shuren said in a joint announcement. Read More