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Digital Health Software Precertification Program News Today : Breaking News, Live Updates & Top Stories | Vimarsana

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Google hires former FDA digital chief Bakul Patel - Vimarsana News

Google hires former FDA digital chief Bakul Patel

Bakul Patel will serve as a senior director at the technology giant. He will focus on global digital health strategy and regulatory affairs.

Podcast: Non-Binding Guidance: FDA Regulatory Developments In AI And Machine Learning - Food, Drugs, Healthcare, Life Sciences - Vimarsana News

Podcast: Non-Binding Guidance: FDA Regulatory Developments In AI And Machine Learning - Food, Drugs, Healthcare, Life Sciences

This installation of Ropes & Gray's podcast series Non-binding Guidance focuses on FDA regulatory developments in the area of artificial intelligence ("AI") and machine learning. AI and machine learning represent a rapidly growing frontier in digital health, with applications ranging from medical device software used for diagnostic and triaging applications to drug candidate selection to clinical trial design and interpretation. In this episode, FDA regulatory attorneys Kellie Combs, Greg Levine, and Sarah Blankstein explore the development and uptake of these technologies in response to the ...

Source: mondaq.com
Apple (AAPL), Mind Cure Health (MCURF) - The Digital Therapeutics Market Is Redefining Psychedelic Research And Patient Care - Vimarsana News

Apple (AAPL), Mind Cure Health (MCURF) - The Digital Therapeutics Market Is Redefining Psychedelic Research And Patient Care

The following article is sponsored by Mind Cure. The information contained in this article in no way represents investment advice or opinion on the part of Benzinga or its writers and is intended for informational purposes only. Digital therapeutics (DTx) are a form of patient care that are gaining momentum in the medical industry and the effects of the pandemic have only accelerated this growth.  In 2019, Insider Intelligence projected that the digital therapeutics industry would reach a market value of $9 billion by 2025. Although last year, their projections increased dramatically with th...

Tidepool Loop App for Diabetes Nears FDA Approval - Vimarsana News

Tidepool Loop App for Diabetes Nears FDA Approval

Tidepool Loop App for Automating Insulin Dosing Now with FDA Written by Mike Hoskins and Amy Tenderich on February 1, 2021 — Fact checked by Jennifer Chesak Courtesy of Tidepool Tidepool Loop, a first-of-its-kind app that will connect with a variety of compatible insulin pumps and continuous glucose monitors (CGMs) to automate insulin dosing, has been submitted for FDA approval. This is big, Diabetes Friends, because new automated insulin delivery (AID) systems are the future of diabetes care, and because the Tidepool Loop project represents over two years of development work aimed at bring...

The 3 Compliance Aspects For Passive Predictive Monitoring Device Success - Vimarsana News

The 3 Compliance Aspects For Passive Predictive Monitoring Device Success

The 3 Compliance Aspects For Passive Predictive Monitoring Device Success By Anna Ronning and Hilde Viroux, PA Consulting The healthcare and life science industry has been undergoing a digital transformation, and the global COVID-19 public health emergency has accelerated the development of at-home monitoring products. With this shift, at-home monitoring devices are focusing on a passive approach collecting data in the background. Understanding the regulatory compliance landscape is critical for getting these products on the market and in patients’ hands quickly. In this article, we define ...