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FDA Eyes Tailored Approach to Regulating AI-Based Medical Devices
FDA Commissioner Scott Gottlieb is making the most of his final week at the agency. In the month that has passed since Gottlieb rattled the medical device industry with news of his impending resignation, the commissioner has issued 18 public statements pertaining to nearly all corners of the agency's realm, from food, tobacco, and cosmetics to drugs and devices. Friday is Gottlieb's last day on the job. On Tuesday, Gottlieb said the agency will consider a new regulatory framework for reviewing medical devices that use advanced artificial intelligence algorithms. AI has been making headlines in medtech for a whi...
Source: MDDI - April 3, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Software Source Type: news

Facebook Makes Its Healthcare Debut
Cristin Moran, CEO of Growth Science, said it best last week at MD&M Minneapolis when she said almost every industry is interested in healthcare. We've already seen Apple, Amazon, Microsoft, and Google make power moves in healthcare, so it should come as no surprise that Facebook has now made its healthcare debut. The social media giant announced this week that it is developing products and partnerships aimed at connecting people with healthcare resources, starting with a new Preventive Health tool for U.S. consumers. Facebook said it is working with U.S. health organizations to offer the new tool, which is...
Source: MDDI - October 30, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Digital Health Source Type: news

Consider the Promises and Challenges of Medical Image Analyses Using Machine Learning
Medical imaging saves millions of lives each year, helping doctors detect and diagnose a wide range of diseases, from cancer and appendicitis to stroke and heart disease. Because non-invasive early disease detection saves so many lives, scientific investment continues to increase. Artifical intelligence (AI) has the potential to revolutionize the medical imaging industry by sifting through mountains of scans quickly and offering providers and patients with life-changing insights into a variety of diseases, injuries, and conditions that may be hard to detect without the supplemental technology. Images are the largest source...
Source: MDDI - June 2, 2020 Category: Medical Devices Authors: Partha S. Anbil and Michael T. Ricci Tags: Imaging Source Type: news