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

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

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 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 ...