Tidepool Completes FDA 510(k) Submission of Tidepool Loop, as reported by businesswire.com, 7 January 2021. Open Source diabetes nonprofit submits automated insulin dosing app for iPhone for FDA review.

Built on the extraordinary foundation of the do-it-yourself diabetes community’s original Loop app, Tidepool Loop is a first-of-its-kind project to take a patient-led innovation and shepherd it through US FDA’s regulatory process with the goal to make the app more broadly accessible to people with diabetes and their clinicians.

The app is designed to connect with a variety of compatible insulin pumps and continuous glucose monitoring systems (CGM) to automatically dose insulin for the treatment of insulin-requiring diabetes in an effort to keep a user’s glucose within a desired correction range. The goal of the interoperable design is to provide flexibility for users and their healthcare teams to choose the compatible components to which they have the best access or with which they are most familiar using in managing their care.

“We are standing on the shoulders of giants — people in the open-source diabetes community who believe management tools should work better together and created software for themselves and their community,” said Howard Look, CEO and co-founder of Tidepool. “Just two years from kicking off the project, we’ve taken that foundation and built a system we’re proud to put in front of FDA. We’re committed to working alongside the agency and our device partners to drive progress in the areas of device interoperability and access, and we look forward to FDA’s review.”

Read more:  Tidepool Completes FDA Submission of Tidepool Loop

Senseonics’ 180-day Eversense glucose monitor delayed at FDA by COVID-19 pandemic was reported by Conor Hale for FierceBiotech.com, 29 December 2020. 

Senseonics’ plans to roll out its new, long-term diabetes sensor implant will be pushed to the middle of next year as FDA reviewers continue to be swamped by product submissions aimed at the COVID-19 pandemic.

The upcoming version of the Senseonics Eversense continuous glucose monitoring system—a smartphone-connected device, first approved in June 2018, that’s inserted completely under the skin—aims to double its life span from 90 days to six months.

But the company has received word from the FDA to expect delays of at least two months for its application while the agency tasks its staff with emergency reviews of coronavirus tests and other medical devices, it said.

Read more:  Senseonics’ 180-day Eversense glucose monitor delayed at FDA

New Diabetes Technology: What to Expect in 2021 was written by Mike Hoskins for DiabetesMine.com, 4 January 2021 … and it is CHOCK FULL of LOTS OF NEWS! 

So much news, I’ll just list the topics.  If you see someone interesting, just click on the link below to the full article.

    • Smartphone control of devices
    • New Insulin pumps and CGMs
    • Connected insulin pens
    • New diabetes tech

Read more:  New Diabetes Technology: What to Expect in 2021

Here comes Amazon into the Healthcare Industry!!! 15 things to know about Amazon’s healthcare strategy heading into 2020 was reported by Laura Dyrda for Beckershospitalreview.com, 6 January 2021.

Over the past year, Amazon has made several big partnerships and investments in the healthcare space, which will likely continue into the new decade. Here are 15 things to know about Amazon’s push into healthcare during 2019 and where they’re headed in 2020.

This is just #1 … be sure to read them all!

Amazon is among the tech giants making the biggest impact on healthcare, and coupled with its vast number of users and sellers, it can be a fertile testing ground for future healthcare applications, according to CBInsights. The company has around 1.2 million employees in Haven, the Amazon-JPMorgan, Berkshire Hathaway partnership. It also has an estimated 5 million sellers and 310 million active users, including 100 million Amazon Prime members.

Read more:  15 things to know about Amazon’s healthcare strategy heading

Hearing loss in diabetes often remains undiscussed was written by Susan Weiner for EndocrineToday.com, 6 January 2021. 

Hearing loss is more common than you might think. There are 34 million U.S. residents with diabetes and about 34.5 million people with hearing loss. Many of those double up. For people who have prediabetes, the rate of hearing loss is 30% higher, and for those who have diabetes, it is twice as common as for those who do not have diabetes. Additionally, hearing loss in a person with diabetes often presents earlier than in those without diabetes, and the risk increases when that person also has co-conditions, such as neuropathies, high blood pressure and cardiovascular disease.

What causes these higher rates of hearing loss among people with diabetes is the same damage that elevated blood glucose has on the other small vessels in the body.  When glucose levels are high, the small vessels in the inner ear start to break. Those broken blood vessels disrupt normal hearing.

Read more: Hearing loss in diabetes

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