The FDA recently released an updated set of data drawn from devices in the GUDID database, which now includes almost 4 million products.

This feature compiles news briefs on a range of US regulatory and legal happenings. This week: Medtronic seeks HeartWare batteries; companies sign health equity pledge; insulin dosing app cleared; recall on field decontamination kits; and the renewal of an FDA panel. 

Medtech Insight spoke to Sidley Austin LLP partner Jeff Senger about the challenges companies may face navigating the FTC’s updated health products guidance.

New data aggregated from over 5,000 reported adverse events suggests that patients should be aware of risks using MitraClip for TEER and operators should take more caution in handling the device.

In an event hosted by the Medical Device Innovation Consortium, cybersecurity experts discussed a benchmark report on the state of cybersecurity in the device industry. The director of digital health product security policy at Medtronic previewed the updated Joint Security Plan.

The trade group says that the Biden Administration should consider the lack of alternatives to ethylene oxide sterilization when considering new regulations on EtO.