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The FDA has issued a warning about counterfeit COVID-19 test kits that are being marketed in the U.S. — including fake Flowflex COVID-19 test kits and iHealth COVID-19 antigen rapid test kits. Read More
The FDA has clarified that it does not plan to regulate most software apps used in public health — such as the case-counting software programs that have been in use throughout the pandemic — as medical devices. Read More
The FDA is making significant organizational changes to the Center for Devices and Radiological Health (CDRH), which plays a lead role within the agency in how medical devices are evaluated or cleared for clinical investigations and marketing. Read More
“False-positive or false-negative results from improper use of these tests could lead to further exposure of uninfected individuals,” the agency said. Read More
Abbott reported that almost nine out of 10 patients treated with its TactiCath sensor-enabled (SE) ablation catheter for persistent atrial fibrillation (AFib) in a clinical study remained symptom-free up to 15 months later. Read More
Distinguishing between devices and drugs for regulatory purposes can be difficult in some cases, but the European Commission’s Medical Device Coordination Group (MDCG) has released a new guidance document that aims to help. Read More