Medtech Insight caught up again with iRhythm CEO Quentin Blackford about his vision for the company as it plans for the next five to ten years of expansion in the remote cardiac monitoring and arrhythmia diagnostics market.

Former FDA principal deputy commissioner Amy Abernethy says cell and gene therapy is an area primed for improved ‘parallel conversation’ between FDA and CMS on data requirements.

Start-up firm, with two Chinese-developed drugs for lung cancer in late-stage development, may be particularly vulnerable to the US Food and Drug Administration’s recently stated opposition to the Chinese-only research supporting Eli Lilly’s sintilimab.

Dexcom received a CE mark for the G7 system in Europe and is awaiting a 510(k) clearance from the US FDA. The G7 is smaller and easier-to-use than the company's G6 CGM and will be more competitive with Abbott's FreeStyle Libre 3 CGM