An FDA panel unanimously rejected J&J's V-Wave Ventura heart shunt, citing risks outweighing benefits despite safety data.

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 ...

FDA panel rejects J&J heart device citing lack of efficacy and unresolved safety issues, delaying market entry for the ...

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

Explore the dark side of India's healthcare system as Kaunain Sherrif reveals the failures of medical regulation, patient ...

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 ...

Brain-computer interfaces will play a central role in defining how human intelligence and artificial intelligence fit together.

INSPIRIS is the leading surgical aortic valve globally around the world. And as mentioned, it has provided extended durability with RESILIA tissue. It is also the only surgical aortic valve with VFit ...

The Dark Secrets of Johnson & Johnson by Gardiner Harris shatters that comforting image. Through investigative reporting, ...

In every way, Taylor Hyma, 18, was a “normal teen.” She went to school, worked, hung out with friends, and took care of herself. Then suddenly, her life began to ...

Lawmakers requested the report after a 2023 ProPublica and Pittsburgh Post-Gazette investigation revealed that the FDA had ...