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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. ....

Bakul Patel , Robert Califf , Brendan Oleary , Karen Desalvo , Amy Abernethy , Digital Health Software Precertification Program , Digital Health Center , Radiological Health , Drug Administration , Health Software Precertification Program , Human Services Department , National Coordinator , Health Information Technology ,

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 bringing do-it-yourself (DIY) “artificial pancreas” innovation into an official, FDA-regulated product that will be broadly available via the iOS app store. ....

Stanford University , United States , Czech Republic , San Francisco , Scott Leibrand , Pete Schwamb , Milos Kozak , Dana Lewis , Hashtag Wearenotwaiting , Melissa Lee , Digital Health Software Precertification Program , Diabetesmine Exchange , Helmsley Charitable , Protocols Initiative , Tidepool Loop , Howard Look , Tandem Diabetes Care , Diabetesmined Data Exchange , D Dad Pete Schwamb , D Dad Milos Kozak , Health Software Precertification Program , Diabetes Care , Education Specialists , Observational Study , Helmsley Charitable Trust , Open Protocols ,

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 “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. ....

United States , United Kingdom , Anna Ronning , Anna Ronning Cohen , Hilde Viroux , Digital Health Software Precertification Program , Cranfield University , Health Insurance Portability , Health Software Precertification Program , All Relevant Privacy , Accountability Act , California Consumer Privacy Act , General Data Protection Regulation , Safety And Accuracy Of Your , Premarket Approval , European Medical Devices , ஒன்றுபட்டது மாநிலங்களில் , ஒன்றுபட்டது கிஂக்டம் , க்ர்யாந்‌ஃபீல்ட் பல்கலைக்கழகம் , அனைத்தும் தொடர்புடையது ப்ரைவஸீ , பொறுப்பு நாடகம் , கலிஃபோர்னியா நுகர்வோர் ப்ரைவஸீ நாடகம் , ஜநரல் தகவல்கள் ப்ரொடெக்ஶந் ஒழுங்குமுறை , பாதுகாப்பு மற்றும் திட்பநுட்பம் ஆஃப் உங்கள் , ஐரோப்பிய மருத்துவ சாதனங்கள் ,