FDA News


Amplatzer Talisman PFO Occluder and Delivery Sheath Get Nods from FDA

September 30, 2021

Abbott announced on September 29 the FDA had granted approval to the Amplatzer Talisman PFO Occluder for use in patients with a PFO at risk of recurrent stroke. This approval was accompanied by the clearance of the Amplatzer Talisman Delivery Sheath.

Cardiology Month in Review: September 2021

September 25, 2021

September's cardiology month in review features FDA news related to empagliflozin and tofacitinib, a study into the potential impact of sacubitril/valsartan's label expansion, and a study from HFSA 2021.

FDA Issues Warning Over Potential Cardiovascular Disease Risk with Tofacitinib

September 10, 2021

Announced in a statement on September 1, the FDA warning is an update to the FDA Drug Safety Communication issued on February 4, 2021 and the results of a review of a trial that found a serious increased risk of CV-related events with the drug.

FDA Approves Rivaroxaban for Use After Lower Extremity Revascularization in Peripheral Artery Disease

August 24, 2021

Announced on August 24, rivaroxaban (Xarelto) has received its ninth indication from the US FDA. This time, the FDA has approved a label expansion to include patients with symptomatic peripheral artery disease who have undergone lower extremity revascularization.