Beta Bionics Appoints Dr. Steven Russell as Chief Medical Officer in Preparation for the Commercial Launch of the iLet Bionic Pancreas System in a press release on NewsWire.com, 4 January 2023. Caution: The iLet Bionic Pancreas is an investigational device limited by Federal law to investigational use. Not available for sale.
Beta Bionics, Inc. — a clinical-stage medical technology company — announced the appointment of Steven Russell, MD, Ph.D., to the role of Chief Medical Officer as the company prepares for the commercial launch of the iLet Bionic Pancreas System.
“As we move closer to commercial launch of the iLet Bionic Pancreas, we have strategically added a wealth of knowledge and experience to our executive team,” explained Sean Saint, President and CEO of Beta Bionics. “Dr. Russell is one of the foremost thought leaders in the field of diabetes technology, and I have turned to him often over the years for his expertise and perspective. His experience with the bionic pancreas in a clinical setting is second to none. There is no better person we could have for our Chief Medical Officer as we complete the regulatory review process and prepare for the U.S. launch of the iLet.”
Dr. Russell is an endocrinologist and diabetologist with 20 years of experience managing diabetes. He is an Associate Professor of Medicine at Harvard Medical School and an attending physician at Massachusetts General Hospital (MGH) Diabetes Associates in Boston, where he has maintained a clinical practice managing diabetes in the outpatient and inpatient settings. Dr. Russell’s research at MGH has been focused on the application of new technologies to improve the care of people with diabetes, including the collaboration with Dr. Ed Damiano’s research group at Boston University to develop and test a wearable bionic pancreas for automated blood glucose control in diabetes. Dr. Russell has directed nearly all of the bionic pancreas clinical trials, including 20 studies in type 1 diabetes, type 2 diabetes, and cystic fibrosis-related diabetes.
“The bionic pancreas project has been the focus of my professional life for many years. Until the completion of the pivotal trial, I felt I was able to bring the most value to the project as an academic physician, providing advice and executing clinical trials,” said Dr. Russell. “Now that the pivotal trial is complete, I think my contributions will be most impactful by providing medical leadership within Beta Bionics as we work to obtain FDA clearance and prepare for the launch of the iLet. I am excited to be part of an all-star team and look forward to supporting people with diabetes and healthcare providers as the iLet emerges from the research setting into clinical use.”
EOFlow Submits 510(k) Application for Disposable Insulin Patch posted on FDANews.com, 3 January 2023.
South Korea-based EOFlow has submitted a 510(k) application to the FDA for its EOPatch, a wearable, disposable insulin pump for diabetes patients. The patch-type pump is placed on the skin and holds 2 mL of insulin. The tubeless pump can be used for three and a half days, the company said.
EOFlow is seeking the FDA’s clearance to launch the device in the U.S. — the world’s largest diabetes market with an estimated 37.3 million diabetics. The patch is already approved in South Korea, Europe, the United Arab Emirates, and Indonesia.
How a new app could help people eat more fruits and vegetables by Annie Lennon for MedicalNewsToday.com, 4 January 2023.
Despite government guidelines to increase fruit and vegetable intake worldwide, consumption in Europe, the United States, and across the globe remains low. Recently, researchers from the University of Bournemouth released a new app called “SMART 5-A-DAY” to help users track and increase their fruit and vegetable intake.
Prof. Katherine Appleton, professor of psychology at the University of Bournemouth and one of the app’s creators, said, “The app is based on the U.K. 5-a-day recommendations, and fruit and vegetable recommendations can vary around the world based on the local fruits and vegetables available, local portion sizes, and other local nutritional concerns. Recommendations to consume lots of fruits and vegetables, however, apply everywhere.”
The app was released in the Google Play Store for Android phones on December 29, 2022.
Potential factors impeding fruit and vegetable intake may include:
- poor knowledge or confusion around nutritious fruits or vegetables
- portion sizes for fruits and vegetables
- the number of portions needed per day
- the need for a variety of fruit and vegetables
- benefits of high fruit and vegetable consumption
Increasing awareness around what constitutes adequate fruit and vegetable consumption could help individuals improve their overall health.
Doctors explain how Wegovy and Ozempic work by Keith Zubrow for 60 Minutes Overtime on CBSNew.com, 1 January 2023.
Among the medications discussed in the report are Wegovy and Ozempic. The drugs are both made by the pharmaceutical company Novo Nordisk and contain the active ingredient semaglutide. Other than their recommended dosage levels, the medications are the same. However, Novo Nordisk applied for approval for them from the Food and Drug Administration under different brand names to treat different conditions. Ozempic was first approved by the FDA as a type 2 diabetes medication in 2017. Wegovy was approved by the FDA as a chronic weight management treatment in 2021.
In the video above, Dr. Caroline Apovian, a weight management specialist at Brigham and Women’s Hospital in Boston, who consults for Novo Nordisk, explains how the medications work.
Read/Watch: Doctors explain how Wegovy and Ozempic work
Drugmakers to raise prices on at least 350 drugs in U.S. in January by Michael Erman and Julie Steenhuysen for Reuters.com, 30 December 2022.
Drugmakers including Pfizer, GlaxoSmithKline, Bristol Myers Squibb, AstraZeneca and Sanofi plan to raise prices in the United States on more than 350 unique drugs in early January, according to data analyzed by healthcare research firm 3 Axis Advisors.
The increases are expected to come as the pharmaceutical industry prepares for the Biden Administration’s Inflation Reduction Act (IRA), which allows the government’s Medicare health program to negotiate prices directly for some drugs starting in 2026. The industry is also contending with inflation and supply chain constraints that have led to higher manufacturing costs.
The increases are on list prices, which do not include rebates to pharmacy benefit managers and other discounts. Antonio Ciaccia, president of 3 Axis, said that drugmakers have focused on launching their drugs at higher prices because of the attention paid to annual price increases. “Drug makers have to take a harder look at calibrating those launch prices out of the gate … so they don’t box themselves into the point where in the future, they can’t price increase their way back into profitability,” he said.
Happy Bob expands to Europe and Canada, integrating with Dexcom CGM by Jutta Haaramo, CEO of HappyBob.app and released on MedTechDive.com, 15 December 2022.
Diabetes tech startup Harald AI today launched Happy Bob in Europe and in Canada giving more ways for users of Dexcom Continuous Glucose Monitoring (CGM) Systems to engage with their diabetes data through the popular Happy Bob App. Through Dexcom’s real-time APIs, Happy Bob users can view their glucose values by quickly glancing at their Apple Watch or iPhone widget, creating groups for support, collecting stars, and receiving time-sensitive information and push notifications. Users can also see their historical data in the app for longer than 24 hours, access the expanded view, see insights on their desktop, and laugh at the in-app personalized messaging, alleviating the stress of daily management and glycemic control.
“Dexcom’s Partner Web API leads the way for the future of connected devices. We are really excited to expand our partnership with Dexcom to Europe and Canada. According to our user data, Happy Bob improves patient engagement with their health data, resulting in improvements in time in range, by combining humor, community, and gamification with real-time glucose, activity, and insulin data.” Says Jutta Haaramo, CEO at Harald AI.
Initially released in 2019, Happy Bob App quickly became popular with CGM users who appreciated the personalized messages and gamification it offered. Embracing a lighter side to diabetes management was a game changer in the digital data space and as a result, users were instantly more engaged and motivated to care for their health. The Happy Bob App is available for download from the Apple App Store and Google Play Store for Dexcom CGM users in the US, Canada, and Europe
As a personal side note, my looping community (Facebook LoopandLearn group) hosted Jutta Haaramo last fall … and my admins have been trying it out. There is a tool that allows us to form our own group, where we can see others’ data and leave notes and comments, as well as modify the emoji. At first, we were all a bit hesitant to let others see how we are managing, day by day, throughout the day. But then it suddenly became normalizing … and diabetes management was less isolating. It’s literally fun and non-intrusive … and the messages are just LOL funny! You can use the app for free, invite your D friends to join in a group, and see how it works for you. It’s simple, fun, not shaming … and we are really enjoying it!
So take a break from your busy life and watch a few videos with Happy Bob!