The Federal Communications Commission recently approved four proposals and seeks comments on four others to increase telemedicine access for rural communities.

Following Sterigenic’s $408m EtO settlement, a securities class action lawsuit has been filed against its parent company Sotera Health Company.

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.