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Apple’s electrocardiograph (ECG) software for over-the-counter use, available as an app, has received a risk downgrade from the FDA to class II (special controls) as opposed to the highest-risk class III category. Read More
The FDA has failed to send Congress a required commitment letter for reauthorization of the Medical Device User Fee Act (MDUFA) by the Jan. 15 deadline. Read More
The agency is working with Endologix to identify patients who may benefit from treatment with the AFX2 device, updating labeling and gathering long-term safety data. Read More
French consumer electronics company Withings, a manufacturer of health status detection devices, is expanding its platform with the acquisition of Paris-based Impeto Medical, including Sudoscan, a technology for detecting peripheral neuropathy. Read More
Companies located outside the European Union (EU) need to designate an EU-authorized representative if they want to sell SARS-CoV-2 in vitro diagnostic devices in EU countries, the EU’s Medical Device Coordination Group (MDCG) has advised. Read More