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 ongoing COVID-19 pandemic, FDA s current
regulatory landscape for these technologies, recent steps FDA has
taken to update its regulatory approach to these tools in
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 the market value of DTx expected to hit nearly $56 billion in the next five years.
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 bringing do-it-yourself (DIY) “artificial pancreas” innovation into an official, FDA-regulated product that will be broadly available via the iOS app store.
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 “passive at-home monitoring products” as non-invasive products that continuously monitor elements of health and collect the user’s data without the direct supervision of a healthcare professional. Organizations must take the following three key compliance aspects into consideration to ensure success.