FDA Archives - Blogs & Articles

Speaker Interview with Elodie Baumfeld Andre 2nd Annual MarketsandMarkets Real-World Data and Life Science Analytics Congress

September 10, 2019 MarketsandMarkets Conferences

Boston, September 9, 2019 – MarketsandMarkets recently interviewed Elodie Baumfeld Andre, Senior Director, Epidemiology Strategy Lead, Worldwide Medical & Safety, Pfizer regarding 2nd Annual MarketsandMarkets Real-World Data and Life Science Analytics Congress taking place on October 24 – 25, 2019 at DoubleTree by Hilton Boston-Downtown . Elodie Baumfeld Andre is the Epidemiology Strategy Lead within the Worldwide Medical & Safety group at Pfizer. In this role, Elodie’s focus is on generating Real World Evidence (RWE) to support regulatory decision-making and driving continued innovation by implementing novel clinical designs and developing operating models. She is…

Technologies Transforming Real-World Evidence (RWE) Evidence in the Pharmaceutical Industry

September 5, 2019September 5, 2019 MarketsandMarkets Conferences

As new drugs are emerging every day, it is very important to ensure that the patients get right and effective treatment. One such step can be taken from Real World Evidence (RWE). In simple words, Real World Evidence means data and information collected outside of a clinical trial. This data can be electronic medical records, medical charts or other medical claims to assess patient outcomes. It is made sure that the patient’s identity is removed from the previous data to maintain the patient’s privacy. However, today’s real-world evidence data is…

FDA approves Artificial Intelligence Software for Identifying Brain Bleeds

January 19, 2019January 19, 2019 cncadmin

According to a recent report, Food and Drug Administration (FDA) has given approval for the software developed by MaxQ AI. The software is an Artificial Intelligence-based solution to diagnose and determine non-contrast CT examination images which is known as brain bleeds. Accipio Ix Intracranial Hemorrhage (ICH) of MaxQ AI uses the artificial intelligence technology platform to analyze head CT images automatically. Aidoc says that it is first of its kind in-depth learning solution to benefit radiologists in workflow group. Without affecting the workflow of the physician, this Healthcare AI technology…

FDA to Update Premarket Guidance for Medical Device Security

December 17, 2018January 18, 2019 MarketsandMarkets Conferences

FDA Commissioner Scott Gottlieb, on 5th September said, “FDA is planning to update its premarket guidance for medical device security.” He further added, “We have made significant progress to improve the cybersecurity of medical devices. But the industry is rapidly evolving with respect to data security and we need to keep up the pace.” This guidance will have recommendations for manufacturers for the protection against moderate and major ricks which are capable of disrupting & exploiting clinical operations through remote attack. He further added that the FDA will share number…