Three years ago this week, Abiomed's Impella heart pump received U.S. Food and Drug Administration (FDA) premarket approval (PMA) for acute myocardial infarction (AMI) cardiogenic shock. At the time of Impella’s FDA PMA approval, the cardiogenic shock survival rate to explant in the Impella Quality Assurance (IQ) Database was 51 percent in the United States1. Today, Impella heart pumps, combined with the adoption of best practices that include the use of Impella pre-percutaneous coronary intervention (PCI), have contributed to a significant increase in cardiogenic shock survival and native heart recovery. New data from the IQ Database on nearly 5,000 patients treated between April 2018 and March 2019 show an increase in survival from 51 percent to 67 percent2, a relative increase of 34 percent in survival.

Increasing demand for innovative diagnostic techniques, neurological disorders and increasing disease awareness are expected to drive growth of virtual reality (VR) in the healthcare market over the next several years, according to new research from Reports and Data. The report projects the market will reach a value of $6.91 billion by 2026. Advancements in the field of information technology (IT), including laptop, computer, internet connectivity and mobile applications will also be a significant factor stimulating market demand.

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.