This week, cardiac monitoring firm AngelMed announced its new name; Tempus nabbed FDA approval for its tumor profiling test; and iRhythm revealed that it’s been subpoenaed by the US Department of Justice.

Angel Medical Systems accomplished several major milestones in 2021, including FDA approval of the second-generation version of The Guardian implantable cardiac detection monitor and patient-warning system for acute coronary syndrome events. CEO Brad Snow talked to Medtech Insight about the company's plans to commercialize The Guardian in 2022.

A US FDA advisory panel unanimously voted down the AngelMed cardiac monitor two years ago. But venture-backed Angel Medical Systems was able to engage with the agency after the panel, and the firm ultimately achieved approval of the device designed to help detect heart attacks earlier. It’s a lesson in firms leveraging all the data they have at their disposal.

A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker.