Edwards' Evoque is the first transcatheter therapy to receive FDA approval for the treatment of tricuspid regurgitation. The FDA-approved labeling says it can improve patients' "health status" but the company may be able to soon upgrade that indication to include a mortality benefit claim, which could give Evoque an important advantage over tricuspid valve repair devices.
The US Food and Drug Administration approved Edwards Lifesciences’ Evoque tricuspid valve replacement system to improve the “health status” of people with symptomatic severe tricuspid regurgitation.
The approval, announced on 1 February, makes Evoque the first FDA-approved transcatheter tricuspid replacement valve. Evoque earned FDA's breakthrough status in 2019 and a CE mark in October 2023....
DeepLook Medical recently announced the commercial rollout of DL Precise, an AI-powered imaging platform that enhances breast cancer screening, at major healthcare institutions across the US.
Clairity’s "first-in-class" mammography-based AI screening tool, Clairity Breast, provides "equitable risk assessments," expanding access to lifesaving early detection for breast cancer, said company founder Connie Lehman.
Abbott received the US FDA nod for its Tendyne system, offering a minimally invasive alternative to replace the valves of patients with severe mitral valve disease who are at risk for open-heart surgery.
SAGA Diagnostics has launched its breast cancer residual and recurrence detection test – Pathlight – in the US. The test’s ultrahigh sensitivity and specificity is rare to see in oncology, the company claimed.
The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.
Abbott received the US FDA nod for its Tendyne system, offering a minimally invasive alternative to replace the valves of patients with severe mitral valve disease who are at risk for open-heart surgery.
SAGA Diagnostics has launched its breast cancer residual and recurrence detection test – Pathlight – in the US. The test’s ultrahigh sensitivity and specificity is rare to see in oncology, the company claimed.
