U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., announced Tuesday the agency is pursuing a new framework in which to review artificial intelligence (AI)-based medical software and devices to ensure ongoing effectiveness and patient safety. The agency released a 20-page discussion paper explaining the need for a new framework, the tenets of a total product lifecycle (TPLC) approach to certification, and examples of potential real-world AI software modifications that may or may not be permitted under the proposed framework. The FDA is asking for comments and feedback from all parties to inform future decisions.

April 2, 2019 — A Swedish review of out-of-hospital cardiac arrest data shows rates of bystander cardiopulmonary ...

A research team from Imperial College London believes a new software could speed up the diagnosis and treatment of patients with faulty cardiac rhythm devices in an emergency setting. The software has been able to identify the make and model of different devices, such as pacemakers and defibrillators, within seconds.

Training interventional radiologists to perform endovascular thrombectomies results in positive outcomes for patients experiencing stroke, according to a study presented at the Society of Interventional Radiology Annual Scientific Meeting, March 23-28 in Austin, Texas.1 Expanding access to this treatment provides patients timely access to this gold-standard treatment.

March 27, 2019 — The Centers for Medicare and Medicaid Services (CMS) proposed to update its national coverage policy ...