HeartLight X3 is the third-generation version of the HeartLight endoscopic laser ablation system for pulmonary vein isolation to treat atrial fibrillation.
CardioFocus Inc. announced the CE mark of its HeartLight X3 endoscopic laser ablation system on March 25.
The Massachusetts-based company plans to start commercial introduction of the HeartLight X3 System in Europe immediately. Current users of earlier...
Preparations for the reauthorization of the Medical Device User Fee Amendments for 2028-2032 are underway, with the US FDA announcing a public meeting for 4 August. After negotiations with industry and other stakeholders, a draft agreement is due to Congress by 15 January 2025.
Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.
The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.
