Panelists considered the technology relatively safe but weren’t swayed by the “statistical gymnastics” needed to find a ...

The outside advisors analyzed the results of the RELIEVE-HF pivotal trial, which randomized 508 patients to either receive ...

J&J is pursuing premarket approval for the heart shunt. Although advisory committees provide recommendations to the FDA, the ...

A genetic variant is likely putting some children suffering with myocarditis—inflammation of the heart muscle—at higher risk ...

Myocarditis is a known — but small — side effect of the mRNA Covid vaccines from Pfizer and Moderna, information that federal ...

The FDA’s Circulatory System Devices Panel voted not to recommend approving use of an interatrial shunt to improve heart failure symptoms and prognosis.In a 0-15 vote, the committee determined risk ...

An FDA advisory panel gave a unanimous verdict for an interatrial shunt in heart failure: no way.

A new study shows that older adults with type 2 diabetes who start treatment with sodium–glucose cotransporter-2 (SGLT-2) ...

A new study shows that older adults with type 2 diabetes who start treatment with sodium–glucose cotransporter-2 (SGLT-2) inhibitors—such as empagliflozin (Jardiance) and dapagliflozin (Farxiga)—or ...