The device giant recalled its Ingenio family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) because there’s a chance they can slip into safety mode, posing a risk to patients. It’s Boston Scientific’s fifth high-risk class I this year.
A recall by Boston Scientific Corp. of its Ingenio heart devices has been labeled as high-risk class I by the US Food and Drug Administration.
The company recalled the Ingenio family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) on 3 June. The firm recalled...
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The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.
